Wednesday, April 22, 2009

Deliberate dumbing down of NHS emergency-room standards 'are putting lives at risk'

Lives are being put at risk by the introduction of medical centres designed to take the pressure off overstretched A& E departments, doctors have warned. Two patients have already been endangered after staff at 'urgent care' centres failed to recognise their symptoms, a survey found. Dozens more of the centres are due to open to prevent patients with minor ailments clogging up emergency departments. In some cases patients must be assessed by GPs or nurses before they are allowed to enter casualty.

The College of Emergency Medicine, which represents A&E doctors, found that a man who had a stroke was sent home from an urgent care centre because staff could not work out what was wrong. He was eventually admitted to hospital and recovered. Urgent care centre staff also failed to spot that a baby had meningitis. Emergency treatment was delayed but the child made a full recovery. The survey, of A&E staff working alongside the centres, did not name which ones were at fault.

John Heyworth, president of the College of Emergency Medicine, said: 'These are worrying examples of things going wrong in urgent care centres. 'In emergency departments we are used to seeing patients who may develop serious complications. 'We want to make sure GPs appreciate the risks and handle things very carefully. 'Speaking to colleagues around the country, our concern is that having a barrier to people actually getting in to A&E is not helpful.' He added: 'Patients tend to know when they are very sick and although around 10 to 20 per cent of patients may use the service inappropriately, the majority will go to their GP if they have a minor problem.'

Discussions to set up urgent care centres, which are particularly used for out-of-hours care, are underway at almost all of the UK's 270 A&E departments. Schemes are already running in Maidstone in Kent, Portsmouth and South-East Hampshire, Huntingdon in Cambridgeshire and Nottingham.

Dr Heyworth said: 'In some cases, where they sit alongside A&E they can work very well, but it is no good imposing them on hospitals and preventing patients from actually getting in. 'Another big worry is that money that should be going into hospital emergency departments is being diverted into these urgent care centres.'

But health bosses say that by preventing 15 'inappropriate' attendances at A&E per day a local primary care trust could save £328,000 a year. If three patients a day were stopped from being admitted to a ward when they would be better off at home, a trust could save £6,000 a day, or £2million a year.

The Department of Health has published a number of strategy documents, including the Direction of Travel for Urgent Care, which make clear that the creation of more urgent care centres is seen as the best way to improve service to patients.

Dr Richard Vautrey, of the British Medical Association's GPs' committee, said: 'We should not assume that GPs are less able to assess risk but we need to recognise that patients themselves are usually able to select the area of the health service they need to access, depending on the severity of their condition.'

A Department of Health spokesman said: ' Urgent care centres play an important role in providing emergency care for non-patients without taking up valuable A&E resources. 'It is for local NHS organisations working with local people to decide whether urgent care centres are a good idea when organising their services. 'We have been clear that any changes to existing services should be based on what is best for patients.'

Doctors from around the country will discuss their concerns about patients being prevented from walking directly into their local A&E at a three-day conference of the College of Emergency Medicine in Brighton from today.


Queue no more

Canada's surprising proposal for fast tracking new drugs to patients

From Canada, the land of long health care queues, comes a genuinely promising idea for speeding new medicines into the hands of patients—a fast track approval process called progressive licensing. Which is exactly what the U.S. needs. In 2007, the Food and Drug Administration (FDA) approved only 19 new drugs, the lowest number since 1983. Last year saw a minor uptick to just 24 new medicines...

Part of the domestic slow down in drug approvals comes from the fact that since the 1980s FDA regulators have more than doubled the number of clinical trials required to get a new drug approved from 30 to about 70. This increase in trials has raised the cost of getting a new drug through the regulatory maze to over $1 billion, thus limiting the number of new drugs that pharmaceutical companies can afford to pursue.

This is where progressive licensing could rescue our creaky pharmaceutical regulatory system. While the final regulations in Canada are still being hammered out, one exciting possibility is that drugmakers could submit some of their new medicines for approval after completing relatively fast and inexpensive Phase 1 and 2 trials. Such trials would provide preliminary information about a drug's safety and efficacy. In exchange for this fast track pre-marketing approval, drugmakers would agree to greater post-marketing surveillance of drug safety. Which means that patients using a new drug would essentially enroll in the equivalent of a Phase 4 trial. This post-marketing information would allow companies and regulators to continually adjust the balance of benefits and risks over the life cycle of new drugs. One important caveat is that such post-marketing scrutiny must not become as costly as the current system of pre-market regulatory review.

Following Canada's preliminary framework, progressive licensing would initially apply just to drugs that address previously unmet medical needs and in those instances where obtaining extensive clinical information is difficult (such as drugs that treat only a small numbers of patients with rare diseases). But why stop there? Canada's free-market Fraser Institute thinks progressive licensing has the potential to fix the current over-regulation of all drugs. Every beneficial drug also has accompanying risks, after all; the question is who gets to weigh the risks and the benefits.

Currently, regulators make the crucial decisions about the risks and benefits of treatment. But this leads to unbalanced benefit-risk evaluations. Remember that from the point of view of pharmaceutical regulators it's far more important to avoid a single highly publicized death from a new drug than it is to worry about the hundreds of unknown patients who die because of delays in approving new life-saving therapies.

In a 2007 report, the Fraser Institute looked at how progressive licensing could be transformed into a more radically open system that allows patients and physicians to evaluate the benefits and risks of new therapies rather than relying on the judgments of timid bureaucrats. In the report, Fraser's Brent Skinner looked at how the risks of new treatments compare to the risks of alternative treatments that the public already accepts.

For example, consider the case of the over-the-counter pain reliever ibuprofen versus the new drug Vioxx. A novel painkiller introduced in 1999, Vioxx was withdrawn from the market because it was found to increase the risk of heart attacks. But further research indicated that many non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, also increase the risk of heart attacks among users.

Both types of medicine effectively relieve pain, but Vioxx had the benefit of reducing the risk of gastrointestinal bleeding, which NSAIDs exacerbate. But who should weight the risk of dying from heart disease versus the risk of dying from bleeding ulcers versus effective pain relief for rheumatoid arthritis? One 1999 study estimated that there are 103,000 hospitalizations and 16,500 deaths in the United States due to complications from NSAID-associated gastric ulcers. As Skinner notes, a patient who is at high risk from gastrointestinal complications might well choose to take the cardiovascular risks associated with Vioxx. Why not let patients and their physicians have this risk information and choose for themselves?

Progressive licensing could modernize the current process from one where bureaucrats grant extensive permission before new drugs hit the market into a system based on initial indications of safety and effectiveness followed by ongoing risk evaluations. This would give patients greater say in their treatment, allowing those who willing to accept a certain amount of risk early access to the latest treatments, while risk-averse patients and physicians could wait until further information became available. It would also increase the scope for private groups—perhaps along the lines of the Underwriters' Laboratories certification process—to evaluate benefits and risks.

Progressive licensing might turn out to be just what the doctors (and patients) ordered for reducing the backlog of new drugs awaiting the nod from overly cautious regulators.


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