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Tag: Adverse Events

Our Dead on Every Shore

By MAYURA DESHPANDE 

I once made a serious error. The patient had taken an overdose of paracetamol, but because I was single-handedly covering three inpatient acute psychiatric wards due to sickness of two other trainees which medical HR had been unable to cover, with a lot of agency nurses who did not know any of the patients well at all, and also because this patient frequently said she had taken overdoses when she had not, and declined to let me take bloods to test for paracetamol levels, I believed she was crying wolf. She collapsed several hours later, and died. I was overwhelmed with feelings of guilt, inadequacy, but also fear – was this the end of my career? I was a trainee psychiatrist at the time – and was immensely fortunate in that my supervising consultant was robust in his defence of me, supported me, whilst fronting the complaint from the patient’s family and attending the inquest. He had been covering two outpatient clinics himself while I was on the ward.

The patient was only 26 years old. Her parents were very angry with me, and not unreasonably so; at the time, it seemed to me that they wanted me to suffer. Twenty years later, I believe they wanted to understand how I made the decision I did. Eventually, the consultant arranged for me to meet the parents. They were very kind to me, all of them, I realise that now. I wasn’t able to give them the answers they wanted. I just cried and said I was sorry.

The mother sent the consultant a letter afterwards which he gave me when I was about to complete that training placement. I did not read it for many months. When I did, I cried. The mother described her daughter’s childhood, the family’s loss, and her own incomprehension that the NHS – which she and generations of her family had venerated as a great institution – could have failed her child. It said very little about me, certainly didn’t seek to blame me, but said a few times that she wanted justice for her daughter. It was an exploration of grief by a bereft mother.

I often think about the mother – I cannot recall the face of the 26 year old patient – but remember perfectly well the mother, who said very little, didn’t even cry, leaving her husband to talk incoherently about justice and a referral to the GMC and the police (they did not do any of these things). And I often ponder the nature of justice they wanted. This was well before the advent of Duty of Candour and rigorously completed serious incident investigations.

Did they get justice? The coroner returned a verdict of suicide, but failed to acknowledge the systemic problems of lack of staff, merely noting that there had a “gap in clinical assessment”. It was not untrue, yet I experienced it as unfair. The consultant reminded me that I was fortunate that the family had not made more fuss. So I let it be. Until the case of Dr Bawa-Garba.

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OpenFDA – the Good, the Bad, and the Ugly

Screen Shot 2014-07-21 at 5.59.57 PM

Adverse Event Reports Since 2004. Source: OpenFDA

On June 3rd, the FDA launched OpenFDA, in an attempt to take large internal datasets and make them more accessible and usable by the developer and business community.

OpenFDA is delivered in a search-based API that should enable software developers to more easily build applications based on adverse event data from the FDA Adverse Event Reporting System (FAERS) dataset for the period 1/1/2004 to 6/30/3013. The FDA has announced plans to add device and food adverse events data to the framework, along with structured product labeling and recall data (update: drug and device recall data was added on July 16).

The launch was heralded with the sort of buzz and hoopla usually reserved for a major product launch from a Silicon Valley startup. We have held off on any analysis and opinion until now to give our team the needed time to look through the system thoroughly.

Now, I readily admit, I am biased. As a data geek with 15+ years working on Big Data problems, I really want to love OpenFDA.  It is, after all, a major step forward both in terms of technology, but more importantly, philosophy from an agency that hasn’t exactly been a shining example of either in recent years.

In an ideal world, OpenFDA could usher in a world of new and improved tools and products that would improve patient safety and adherence, increase physician awareness of drug safety dangers, assist healthcare decision makers who are driving prescribing behavior with better decision support, and lower the overall cost of care by reducing avoidable side effects.

But we don’t live in an ideal world.

So, here are my thoughts on the Good, Bad, and Ugly of OpenFDA:

The Good:

OpenFDA is a seal of approval over the use of FAERS data in multiple settings. This is the first time that FDA has confirmed what we have believed all along – that these data are valuable and should be used in multiple venues to improve patient safety. It has long seemed ridiculous that the FDA spends millions of dollars to collect these data, uses it for their own internal safety signaling and review processes, but then deters others in the healthcare community from deploying these same data in new and innovative ways.

OpenFDA gives the long awaited ‘all-clear’ to harness the power of these data to improve care throughout the healthcare system.   We’re excited to see how this evolves in the product space – especially at the patient level – in the months and years ahead.

The Bad:

As with any new launch, once the excitement dies down, the true capabilities and limitations of the system are revealed. After careful review we’ve discovered several major concerns, two of the big ones are detailed below:

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Penalizing Hospitals For Being Unsafe

Ashish JhaAdverse events – when bad things happen to patients because of what we as medical professionals do – are a leading cause of suffering and death in the U.S. and globally.  Indeed, as I have written before, patient safety is a major issue in American healthcare, and one that has gotten far too little attention. Tens of thousands of Americans die needlessly because of preventable infections, medication errors, surgical mishaps, and so forth.  As I wrote previously, according to Office of Inspector General (OIG), when an older American walks into a hospital, he or she has about a 1 in 4 chance of suffering some sort of injury during their stay.  Many of these are debilitating, life-threatening, or even fatal.  Things are not much better for younger Americans.

Given the magnitude of the problem, many of us have decried the surprising lack of attention and focus on this issue from policymakers.  Well, things are changing – and while some of that change is good, some of it worries me.  Congress, as part of the Affordable Care Act, required Centers for Medicare and Medicaid Services (CMS) to penalize hospitals that had high rates of “HACs” – Hospital Acquired Conditions.  CMS has done the best it can, putting together a combination of infections (as identified through clinical surveillance and reported to the CDC) and other complications (as identified through the Patient Safety Indicators, or PSIs).  PSIs are useful – they use algorithms to identify complications coded in the billing data that hospitals send to CMS.  However, there are three potential problems with PSIs:  hospitals vary in how hard they look for complications, they vary in how diligently they code complications, and finally, although PSIs are risk-adjusted, their risk-adjustment is not very good — and sicker patients generally have more complications.

So, HACs are imperfect – but the bottom line is, every metric is imperfect.  Are HACs particularly imperfect?  Are the problems with HACs worse than with other measures?  I think we have some reason to be concerned.

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What the Work of the Inspector General Tells Us about Patient Safety…

March 2nd through the 8th were National Patient Safety Awareness Week – I don’t really know what that means either.  We seem to have a lot of these kinds of days and weeks – my daughters pointed out that March 4 was National Pancake Day – with resultant implications for our family meals.

But back to patient safety and National Patient Safety Awareness Week. In recognition, I thought it would be useful to talk about one organization that is doing so much to raise our awareness of the issues of patient safety.  Which organization is this?  Who seems to be leading the charge, reminding us of the urgent, unfinished agenda around patient safety?

It’s an unlikely one:  The Office of the Inspector General of the Department of Health and Human Services.  Yes, the OIG.  This oversight agency strikes fear into the hearts of bureaucrats: OIG usually goes after improper behavior of federal employees, investigates fraud, and makes sure your tax dollars are being used for the purposes Congress intended.

In 2006, Congress asked the OIG to examine how often “never events” occur and whether the Centers for Medicare and Medicaid Services (CMS) adequately denies payments for them.  The OIG took this Congressional request to heart and has, at least in my mind, used it for far greater good:  to begin to look at issues of patient safety far more broadly.

Taken from one lens, the OIG’s approach makes sense:  the federal government spends hundreds of billions of dollars on healthcare for older and disabled Americans and Congress obviously never intended those dollars pay for harmful care.  So, the OIG thinks patient safety is part of its role in oversight, and thank goodness it does.

Because in a world where patient safety gets a lot of discussion but much less action, the OIG keeps the issue on the front burner, reminding us of the human toll of inaction.

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