Special report: Prescription medicines

Each year, Britons are dying in their thousands because of the side effects of prescription and over-the-counter medicines. Reported deaths are up 155 per cent in a decade – and experts are seeking new safeguards. Nina Lakhani reports
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Thousands of patients are dying each year as a result of side effects from pills prescribed by GPs and hospital doctors.

And while the number of deaths from suspected adverse reactions to prescription drugs has more than doubled in the past 10 years to 973 last year, medical experts warn that as few as one in 10 deaths and other serious complications are being reported.

Doctors' poor prescribing skills and repeated failures to recognise accurately adverse drug reactions in patients have seen deaths multiply by about two and half times since 1996.

Experts are calling for a revamp of the current warning systems designed to alert doctors to potentially lethal prescription drug treatments.

They believe tens of thousands of patients suffer life-threatening, disabling or other serious reactions that need hospital treatment because of a failure to spot and report many dangerous side effects and drug interactions quickly enough.

One study estimated that the equivalent of all the beds from seven general hospitals – 5,600 places – are occupied with patients suffering from drug reactions at any one time, costing the NHS more than £450m each year. Researchers believe around 70 per cent of adverse reactions could be avoided through better training, computerised prescribing systems and staff spending more time talking and listening to patients.

The latest revelations follow The Independent on Sunday's exclusive report two months ago highlighting the dramatic rise in the number of drugs that doctors are now prescribing.

The report in August showed that the NHS faced an £8.2bn bill for prescription medicines in England in 2006, as doctors issued 51 per cent more drugs than they did 10 years earlier.

But today's revelations highlight a 155 per cent rise in reported deaths from adverse reactions to prescribed and over-the-counter drugs – a far steeper increase that will shock the both medical profession and patient groups.

An international conference on drug safety which convenes in Bournemouth tomorrow will hear that "too little progress" has been made in the past 15 years in training doctors to use medications more safely.

Professor Saad Shakir, director of the Drug Safety Research Unit at Southampton University, said: "Doctors need to know how to use medications – this is the most important ethical responsibility for us. Surgeons wouldn't conduct an operation they haven't studied and trained for, and these same standards should apply to medications.

"The competence of doctors in understanding medicines, knowing when and how to use them and how to recognise problems is as essential as training a surgeon in how to perform an operation. Using medicine should be a part of medical training and the ongoing monitoring and evaluation of doctors."

The British Medical Association said last night that the figures amounted to a "wake-up call" and is calling for better training in the medical profession. Dr Peter Maguire, deputy chairman of the BMA Board of Science, said: "This big rise in fatal and serious adverse drug reactions should be a wake-up call to all doctors. We have a large number of new medications, but there are also fake drugs coming into the market, and more and more people are using herbal and over-the-counter drugs, as well as all the existing prescription drugs. On top of that, people are living longer and we have the situation of polypharmacy, where we treat people with several medications.

"In recent years, there has been less pharmacology taught in medical schools, but if you consider the growing number of drugs available and the trend towards combination therapies, then this does seem to go against the grain."

But some experts argue that the task of knowing all potentially harmful drug reactions is beyond doctors, and that computerised prescription systems must be used.

Professor Lucian Leape, patient safety expert from the Harvard School of Public Health in the US, said: "The trouble with education is that it is never 100 per cent effective. The best way is to use a computer system that doesn't forget which medication the patient is allergic to, or that they have impaired kidneys, whereas the doctor may be considering 30 different things.

"By using a correctly programmed computer, we believe you can reduce prescribing errors by 90 per cent."

Many of the reported deaths are linked to older common medications such as aspirin, rather than newer drugs. Doctors and patient groups believe the danger lies with interactions between new and old drugs, which are increasingly combined to treat older patients with multiple diseases. Age Concern warns that elderly patients are more likely to suffer from side effects and are less likely to tolerate a combination of medications.

A failure by doctors to make the difficult distinction between adverse reactions and disease symptoms can prove potentially fatal, as patients may be given drugs that are more harmful than helpful. According to patient groups, doctors and other health professionals do not always take the suspicions of patients and relatives sufficiently seriously.

Penny Bunn was prescribed anti-depressants by a psychiatrist in 1998 when she was a slim 30-year-old broadcast assistant at the BBC. Five years later, she was in hospital with kidney and liver damage, weighing 20 stone. Eventually she was diagnosed as suffering adverse reactions to her prescribed drugs.

As well as serious weight gain, she experienced blurred vision, vomiting, jaundice, irregular periods, agitation and difficulty passing urine. But because none of these symptoms was recognised as adverse drug reactions, Ms Bunn was prescribed more and more medication, eventually leaving her close to death.

She said: "We now know that I am allergic to all anti-depressants. However, rather than even consider this as an option at the time, the consultant psychiatrist continued to blunder blindly on, misdiagnosing all the reactions I was having as being evidence of further psychiatric disorders.

"No medical personnel ever mentioned anything about side effects or interactions, yet I now know some of the medications I was given are not meant to be used together. How the psychiatrist managed to sit there, as I changed before his eyes, and never cotton on to the fact that there was something horribly wrong with what he was doing, I do not know."

Munir Pirmohamed, professor of clinical pharmacology at Liverpool University, said doctors' failure to spot adverse drug reactions was the most important reason for the under-reporting of the problem.

He said the Yellow Card scheme – as the warning system is known – had improved public safety by encouraging more reporting, but that this alone was not good enough: "The Yellow Card scheme needs to be complemented by other methodologies so that we can detect adverse drug reactions sooner rather than later."

Drug trials include relatively few tests on healthy individuals over a short period of time and may not pick up any number of adverse reactions. And interactions between new and older drugs are not tested during clinical trials, so these dangers can only be identified after a drug is licensed and in effect "tested" in the real world.

Professor Shakir said that the current drug safety systems were "... about firefighting and damage limitation, whereas it needs to be more proactive, and though this is starting to take place we don't know the impact of this yet."

Doctors and patient groups stress that people should not stop taking their prescribed medications, but that there is a need for them to be more alert and assertive with their doctors, especially as demand grows for quicker access to new drugs.

Professor Pirmohamed said: "If people are going to get earlier access to new drugs, then an increase in serious adverse drug reaction is a worry, but this is a debate for everyone, including patients, who are often willing to take the risk in order to get access to new drugs more quickly."

Some experts are calling for the pharmaceutical industry to be given more responsibility in this post-marketing surveillance and a more pro-active approach than the Yellow Card scheme, which has been underused since it began over 40 years ago. Drug companies are not currently responsible for monitoring a new product once it is licensed for use, nor do doctors and other professionals have to report any side effects in their patients.

But Professor Shakir said: "I believe identifying, responding to and reporting adverse drug reactions should be included in NHS targets, so that doctors see it as part of their job."

Deadly side effects

The drugs most often reported to have produced fatal reactions in patients (1996-2006)

Clozapine: an anti-psychotic

Infliximab: an anti-inflamma-tory

Diclofenac: an anti-inflammatory

Warfarin: prevents blood clots

Olanzapine: an anti-psychotic

Venlafaxine: an anti-depressant

Aspirin: prevents blood clots

Methotrexate: treats cancer and rheumatoid arthritis

Paroxetine: an anti-depressant

Rofecoxib (Vioxx): an anti-inflammatory

Source: MHRA

The risks

'Dad had a right to know about the side effects'

Retired RAF Squadron Leader Charlie Bootle (right) died in 2001 from an adverse reaction to Methotrexate.

Sqn Ldr Bootle had been taking the well-known medication for rheumatoid arthritis for three months. His daughter, Amanda, describes the events leading up to his untimely death.

"My dad was a fit 72-year-old and a keen sailor who suffered from rheumatoid arthritis. He started to feel breathless out of the blue and when it got worse after a couple of days he and my mum worked out it could be the medication, so they went straight to his GP, who sent him to hospital.

"He kept telling the doctors what he thought but they wouldn't listen because he was just the patient. In the meantime his condition deteriorated so quickly he was dead within days. The hospital told us they didn't warn patients about all the risks of the drug in case people didn't take it, but this is a doctor playing God. My dad had a right to know.

"He should have been allowed to make an informed choice and know what side effects to look out for. That could have saved his life. The National Patient Safety Agency has since issued safety alerts but it scares me that while this drug saves lives, many patients still don't know all the risks. Doctors have to tell their patients: everyone has a right to know." NL

'How can patients take in complex information?'

Chris Steele is a GP and resident doctor on ITV's 'This Morning'.

"I had to miss my slot on 'This Morning' last week as on Tuesday I developed a problem with my heart. It was beating slower than usual and started skipping beats. I went to my local A&E, where I was given an ECG and other tests, and then diagnosed with an adverse reaction to Atenolol, a common medication for high blood pressure, which I've taken for 10 years.

"The medication hadn't changed but my heart has got weaker with age so I am more susceptible to side effects. What worries me is that I'm not sure a normal patient would have noticed or acted on the symptoms so quickly. I'm a doctor so I knew I needed help and that my condition could have developed into cardiac failure. The whole area of medication side effects, interactions between drugs, herbal remedies and foods is a nightmare.

"Doctors don't have the time to keep up to date with all the information out there or to extract all the relevant information from patients in a 10-minute consultation. It's just not possible.

"And how can we expect patients to comprehend the complicated information in the medication leaflets provided? Many elderly patients cannot even read the small print. This is such a complex issue and I really don't know what the answer is." NL

The Pill Epidemic

Deaths from adverse reactions to prescription drugs have doubled in ten years. What should be done about this? Are pills handed out too easily? Should doctors receive more training in how to spot adverse reactions? Or should patients be educated to better detect these in themselves?

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