How Many Die from Medical Mistakes in U.S. Hospitals? ( between 210,000 and 440,000 patients each year )

An updated estimate says it could be at least 210,000 patients a year, more than twice the number in a frequently quoted Institute of Medicine report

By Marshall Allen and ProPublica  | Friday, September 20, 2013 |

surgeon and surgery
ULTIMATE MALPRACTICE: An updated estimate says at least 210,000 patients die from medical mistakes in U.S. hospitals a year.Image: Flickr/U.S. Naval Forces Central Command/U.S. Fifth Fleet

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It seems that every time researchers estimate how often a medical mistake contributes to a hospital patient’s death, the numbers come out worse.

In 1999, the Institute of Medicine published the famous “To Err Is Human” report, which dropped a bombshell on the medical community by reporting that up to 98,000 people a year die because of mistakes in hospitals. The number was initially disputed, but is now widely accepted by doctors and hospital officials 2014 and quoted ubiquitously in the media.

In 2010, the Office of Inspector General for Health and Human Services said that bad hospital care contributed to the deaths of 180,000 patients in Medicare alone in a given year.

Now comes a study in the current issue of the Journal of Patient Safety that says the numbers may be much higher 2014 between 210,000 and 440,000 patients each year who go to the hospital for care suffer some type of preventable harm that contributes to their death, the study says.

That would make medical errors the third-leading cause of death in America, behind heart disease, which is the first, and cancer, which is second.

The new estimates were developed by John T. James, a toxicologist at NASA‘s space center in Houston who runs an advocacy organization called Patient Safety America. James has also written a book about the death of his 19-year-old son after what James maintains was negligent hospital care.

Asked about the higher estimates, a spokesman for the American Hospital Association said the group has more confidence in the IOM’s estimate of 98,000 deaths. ProPublica asked three prominent patient safety researchers to review James’ study, however, and all said his methods and findings were credible.

What’s the right number? Nobody knows for sure. There’s never been an actual count of how many patients experience preventable harm. So we’re left with approximations, which are imperfect in part because of inaccuracies in medical records and the reluctance of some providers to report mistakes.

Patient safety experts say measuring the problem is nonetheless important because estimates bring awareness and research dollars to a major public health problem that persists despite decades of improvement efforts.

“We need to get a sense of the magnitude of this,” James said in an interview.

James based his estimates on the findings of four recent studies that identified preventable harm suffered by patients 2013 known as “adverse events” in the medical vernacular 2013 using use a screening method called the Global Trigger Tool, which guides reviewers through medical records, searching for signs of infection, injury or error. Medical records flagged during the initial screening are reviewed by a doctor, who determines the extent of the harm.

In the four studies, which examined records of more than 4,200 patients hospitalized between 2002 and 2008, researchers found serious adverse events in as many as 21 percent of cases reviewed and rates of lethal adverse events as high as 1.4 percent of cases.

By combining the findings and extrapolating across 34 million hospitalizations in 2007, James concluded that preventable errors contribute to the deaths of 210,000 hospital patients annually.

That is the baseline. The actual number more than doubles, James reasoned, because the trigger tool doesn’t catch errors in which treatment should have been provided but wasn’t, because it’s known that medical records are missing some evidence of harm, and because diagnostic errors aren’t captured.

An estimate of 440,000 deaths from care in hospitals “is roughly one-sixth of all deaths that occur in the United States each year,” James wrote in his study. He also cited other research that’s shown hospital reporting systems and peer-review capture only a fraction of patient harm or negligent care.

“Perhaps it is time for a national patient bill of rights for hospitalized patients,” James wrote. “All evidence points to the need for much more patient involvement in identifying harmful events and participating in rigorous follow-up investigations to identify root causes.”

Dr. Lucian Leape, a Harvard pediatrician who is referred to the “father of patient safety,” was on the committee that wrote the “To Err Is Human” report. He told ProPublica that he has confidence in the four studies and the estimate by James.

Members of the Institute of Medicine committee knew at the time that their estimate of medical errors was low, he said. “It was based on a rather crude method compared to what we do now,” Leape said. Plus, medicine has become much more complex in recent decades, which leads to more mistakes, he said.

Dr. David Classen, one of the leading developers of the Global Trigger Tool, said the James study is a sound use of the tool and a “great contribution.” He said it’s important to update the numbers from the “To Err Is Human” report because in addition to the obvious suffering, preventable harm leads to enormous financial costs.

Dr. Marty Makary, a surgeon at The Johns Hopkins Hospital whose book “Unaccountable” calls for greater transparency in health care, said the James estimate shows that eliminating medical errors must become a national priority. He said it’s also important to increase the awareness of the potential of unintended consequences when doctors perform procedure and tests. The risk of harm needs to be factored into conversations with patients, he said.

Leape, Classen and Makary all said it’s time to stop citing the 98,000 number.

Still, hospital association spokesman Akin Demehin said the group is sticking with the Institute of Medicine’s estimate. Demehin said the IOM figure is based on a larger sampling of medical charts and that there’s no consensus the Global Trigger Tool can be used to make a nationwide estimate. He said the tool is better suited for use in individual hospitals.

The AHA is not attempting to come up with its own estimate, Demehin said.

Dr. David Mayer, the vice president of quality and safety at Maryland-based MedStar Health, said people can make arguments about how many patient deaths are hastened by poor hospital care, but that’s not really the point. All the estimates, even on the low end, expose a crisis, he said.

“Way too many people are being harmed by unintentional medical error,” Mayer said, “and it needs to be corrected.”

See how you can help ProPublica investigate patient safety and join our Facebook group on the topic.

http://www.scientificamerican.com/article.cfm?id=how-many-die-from-medical-mistakes-in-us-hospitals

Roche under investigation by UK watchdogs

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Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 ‘adverse reactions

PUBLISHED:16:48 EST, 7 July 2012 | UPDATED:08:20 EST, 8 July 2012

One of the world’s biggest drug companies is at the centre of an urgent investigation after failing to disclose reports that 15,000 people died while taking its medicines.

Swiss pharmaceutical giant Roche failed to pass on a further 65,000 reports of suspected side effects that were recorded by patients.

All of the reactions took place in the United States over the past 15 years with medicines used to treat breast cancer, bowel cancer, hepatitis B, and skin and eye conditions.

Roche, one of the world’s biggest drug companies, is at the centre of an urgent investigation after failing to report that people died while taking their medication

There is no evidence so far of  any direct link between the problems and the drugs – but medicines watchdogs say they are taking Roche’s failure to disclose possible concerns ‘extremely seriously’.

The drugs involved include Herceptin, given to about 10,000 breast cancer patients in Britain, and Lucentis, which is used to treat about 20,000 UK patients a year with age-related vision loss. The NHS pays Roche millions of pounds for these treatments every year.

The extent of the failings were discovered when the UK medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), carried out a routine inspection of Roche’s drug safety procedures at its headquarters in Welwyn Garden City, Hertfordshire.

The company has now been ordered by the MHRA and the EU-wide regulator, the European Medicines Agency, to investigate immediately each of the total 80,000 deaths and side effects reported. Both agencies said they were ‘taking action’ over Roche’s failures.

All of the deaths and possible adverse  reactions were reported by patients who rang a call centre run by  Roche’s US subsidiary Genentech. Staff there failed to pass on the  reports to Roche’s drug safety team – but it is not known why

Professor Sir Kent Woods, chief executive of the MHRA, said: ‘Patients should continue to take their medicines because our investigation has currently found no evidence of a safety risk to patients.

‘Roche’s actions are unacceptable and our investigation has identified that its reporting systems are inadequate. We are taking urgent action to ensure that these are rectified by Roche as a matter of priority. We will take action to ensure that patients are protected now and in the future.’

All of the deaths and possible adverse reactions were reported by patients who rang a call centre run by Roche’s US subsidiary Genentech. Staff there failed to pass on the reports to Roche’s drug safety team – but it is not known why.

Roche, which made profits of £6.3 billion in 2010, has a legal duty to examine every suspected side effect and report them to regulators around the world so that potential safety concerns can be investigated.

This means that each side effect reported to the patient support call centre should have been immediately sent to the safety team to be assessed.

These must then be sent to regulators – within 15 days for the most serious reactions – even if no link between the drug and the reaction be proved.

Some of the call centre’s records, which date back to 1997, are said to have been noted down on paper and kept in boxes.

The European Medicines Agency, which made the findings public, said: ‘There is at present no evidence of a negative impact for patients and while the investigations and being conducted there is no need for patients or healthcare professionals to take any action.’

A number of drugs are being investigated following the incident

However, a spokeswoman  added: ‘It’s not often we make statements on such findings, so we do take this incredibly seriously. The numbers are huge but we’re not talking about confirmed reactions.

‘Some might not be related, and some may have already been reported to the regulators via other mechanisms – for example directly to us by doctors.’ But she added: ‘We cannot rule out that additional safety concerns could be discovered.’

When asked if legal action could be taken against Roche, she said: ‘We are looking at all options. There are penalty regulations and they could be fined.’

Other drugs being examined  include Avastin, used for bowel and breast cancer; lung cancer medication Tarceva; Rituxan, which treats non-Hodgkin’s lymphoma; the stroke drug Alteplase; Actemra for rheumatoid arthritis; Pegasys for hepatitis B; and Raptiva for the skin condition psoriasis.

If any new safety concerns emerge after examining the data, regulators could decide to withdraw the drugs or change their guidance to doctors.

In a statement, Roche said: ‘Patient safety is of paramount importance to Roche. We acknowledge the concerns that can be caused by this issue for people using our medicines.

‘The non-assessment and non-reporting of these adverse events was not intentional and we are taking comprehensive steps necessary to address the findings of the MHRA inspection. We have provided initial estimates of missed adverse events and are in the process of confirming the final number.

‘We expect to complete all activities related to these programmes as soon as possible.’