“The scandal isn't what's illegal, the scandal is what's legal”

This quote, attributed to Michael Kinsley, is applicable to a very disturbing trend that is having an increasing impact on antimicrobial availability: the acquisition of exclusive marketing rights (usually by small private firms) to inexpensive generic drugs in order to jack up their prices astronomically. The antimicrobials pyrimethamine, albendazole, cycloserine, flucytosine, and doxycycline have all experienced price increases of up to 5000%, and there have been several recent posts on the Emerging Infections Network about how this is limiting availability of these agents for those who desperately need them. 

I hope this NY Times story about the pyrimethamine saga draws more attention to this trend, and leads to some regulatory reforms to prevent this obvious price gouging. Because you-guessed-it, there is nothing illegal about this under U.S. law.

Fortunately, because it engenders bad press when people suffer and/or die due to unavailability of an essential drug, some of these “pharmaceutical companies”* will immediately send out the drug at a reduced price (or even without charge) if contacted by the treating physician. Such saints, these folks are….

*I put that term in quotes, because the company that owns marketing rights to pyrimethamine is founded and run by a hedge fund manager

Is the white coat needed for identification?

If you haven't read Phil Lederer's piece on the white coat at the Conversation, I recommend that you do so. It is very well written and has stimulated a lot of discussion. One of the take-aways for me is that even among many of those who believe we should ditch the white coat, the one argument that gives them pause is the role of the white coat as a means of identification. This is particularly an issue for women and racial minorities, groups that have been historically underrepresented in medicine.

I have two problems with the argument that the white coat is needed for identification. First, unlike the situation in the 1960s, white coats are no longer exclusively worn by physicians. Members of practically every occupational group in the hospital (with the typical exception of students) may wear a long white coat. It's worn by chaplains, administrative assistants, nurse practitioners, physician assistants, you name it. The white coat no longer signifies that the wearer is a doctor. And we have more specific means of identification. Many hospitals now have large occupation-label tags attached to photo IDs (mine is shown), which should be more effective than the type of coat worn.

The second issue I'll articulate is controversial and will probably get me into trouble, but I think it's an important argument to explore. I'm really bothered when a physician says, "If I don't wear a white coat, patients think I'm a nurse." To feel insulted that someone might think you are a nurse implies what you really think about nurses--that they are beneath you. Would an internist (male or female) feel disrespected if someone thought he/she were a neurosurgeon or the chair of the department? I doubt it. And I've mentioned previously that I've been mistaken for a nurse or respiratory therapist many times when I'm wearing scrubs in the hospital, though less so now that I wear my name tag on my scrub shirt (I used to wear my name tag on my waist band but that's not allowed at Iowa). I don't find being misidentified insulting in the least. I just simply answer that I don't have the keys to the medication room or that I'm probably not the best person to change the ventilator settings.

Several years ago (long before I began thinking about killing the white coat) my wife and I and several other people were at a dinner with a visiting professor. My wife made a comment during the conversation about something medical and he said, “Oh, are you a nurse?” She said quite nicely, “no, I’m an oncologist.” He replied, “I’m so sorry that I asked if you were a nurse.” And she said, “Don’t be sorry! I was a nurse. I loved being a nurse. And if tomorrow I were a nurse again, I'd be very happy.” We discussed that interaction last night. As she reflected on the white coat issue, she pointed out that she thinks it's great when a person is proud of their profession, and how the white coat for many people symbolizes that pride and their achievement of completing a very long journey. For some, it also symbolizes the enormous barriers that they have overcome. But she noted that the white coat should not be used as a symbol of who you are not.

I've come to realize that a physician feeling insulted if someone misidentifies them is yet another negative manifestation of professionalism. We as physicians have been socialized to think that we are elite, that we are at the top of the pecking order, that we are better than all the other people who work in health care. That has been given to us unfortunately by our physician colleagues and is part of our culture.

I don’t want to be (or even appear to be) insensitive. I realize that as a white man I’ll never know what it feels like to be an African American woman. But we are trying to eliminate the white coat for patient safety, which should trump all else. Remember that one of the good tenets of medical professionalism, at least historically, is that the patient comes first. Moreover, we are all called, regardless of race or gender or socioeconomic status, to respect all humans (ahh, humanism!). And to verbalize disdain at being identified as a member of another occupation, in my opinion, is classist and incredibly disrespectful.

Ok, I'll get off my soapbox now and let the arrow slinging begin.

What can infection control learn from aviation safety?

We all like to believe that we work in a safe healthcare environment - one that is safe for our patients and colleagues. But the truth is, we care more about our own feelings and time than we do about patient and healthcare worker safety. 

We've discussed the white coat "debate" and the contact precaution "debate" many times already on this blog and elsewhere. If you want to see a nice overview of the white coat debate, Phil Lederer has a new post up on The Conversation. Thus, I don't want to get into the specifics too much, but as a reminder, clinicians wear white coats to carry things, stay warm and as part of our professional uniform. As far as contact precautions, we wear them to significantly (clinical and statistical significance) reduce MRSA infections with the majority of evidence suggesting contact precautions prevent transmission of clinically significant pathogens in inpatient settings.

The major barrier is that healthcare workers hate contact precuations (time, inconvenience) and cling to their white coats and no matter how much evidence we provide them through RCTs, cluster-RCTs and molecular epi studies, they will selectively interpret the data within their own subjective reality (ie cognitive bias). So when our patient safety leaders/deciders are immune from scientfic data (ie the BUGG study or the hundreds of studies that show white coats are covered in pathogens), what are we to do? How can we possibly overcome their cognitive bias (which they hide behind by demanding more and more cluster-RCTs)?

The first thing we can do is point them to the patient safety movement's favorite target: aviation safety. In aviation safety, do they require cluster randomized trials before making us put our tray tables up during takeoff or before banning us from sleeping in the aisles? Is their an RCT that proves that only folks 13yo and older can sit in an exit row? The answer is no. Airline safety is built on logic and scientific evidence but not randomzied trials. For example, you could test to see at what age children can open and lift an exit door safely and use that as a cut-off for setting age restrictions in exit rows. Amazing, huh?  The equivalent in patient safety would be the dozens of studies showing that white coats are coated with pathogens and that long sleeves touch patients. With that level of evidence, an airline safety person would ban white coats in 30 seconds. They wouldn't care if it's inconvenient to carry your iPad without a white coat, just like they don't care that it's inconvenient to put your 5 pound laptop away before landing. Common sense prevails in airline safety! It should also prevail in infection control.

So how do we ultimately create a safe healthcare environment? First, we should continue to demand the highest level of evidence and funding for trials that help develop and test new patient-safety interventions. But in the meantime, we need to put our patients first by using the proven tools (contact precautions) and scientifically sound policies (bare below the elbows) that we already have at our disposal. The highly resistant bacterial pathogens aren't going to sit around waiting for a $20 million dollar cluster randomized trial proving white coats harm patients. And even if they did, there would be folks who would find reasons not to listen anyway - it's cold! Just like aviation safety experts do, we should use the best data available and common sense to make for the safest hospitals today and we should also acknowledge how our cognitive biases cloud our decision making.

To have a truly safe healthcare system, we need to put our patients' safety first and not hide behind a lack of cluster-RCTs that may never be done. If we follow the logic of folks clinging to their white coats or contact precaution deniers, we will soon not even have to wash our hands between patients. Wait, we already don't wash our hands you say? Yes - my point exactly.

Let's degown for good

There's a new paper in the American Journal of Infection Control by Keith Kaye's group at Wayne State. The paper is entitled Degowning the controversies of contact precautions for methicillin-resistant Staphylococcus aureus, and it's a systematic review of the literature on the use of contact precautions to prevent transmission of MRSA in the endemic setting. I'll cut to the chase, so spoiler alert for anyone who doesn't want to know what they found until they can read the paper. The authors concluded that contact precautions does not reduce transmission of MRSA.

Every day in the US there are roughly 500,000 people who are hospitalized. If 5% of those inpatients are isolated for MRSA, there are 25,000 persons isolated daily. That's a lot of plastic, paper and tormented patients and healthcare workers. Based on a previous study that determined that on average 48 gowns and pairs of gloves are used per contact precautions patient per day at a cost of $35, that amounts to 1.2 million sets of PPE daily, with a national daily cost of isolation of $875,000. On an annual basis, that's 438 million sets of PPE at a cost of $319 million. And this results in the generation of 49 million pounds of garbage yearly. In lean thinking, that's a lot of muda. 

Guest Post: AHRQ Report Calls for Environmental Cleaning Research

This guest post was written by Alexandra McGhie, Megan Campbell and Nick Graves to highlight a new AHRQ Report as it relates to an NHMRC (Australia) Partnership Grant led by Queensland University of Technology (QUT) & The Wesley-St. Andrew’s Research Institute (WSARI) called REACH.

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New report calls for further research examining the impact of environmental cleaning interventions on Healthcare Associated Infection (HAI) rates

A new report by the US Agency for Healthcare Research and Quality (AHRQ) calls for further studies on emerging strategies for environmental cleaning and their impact on healthcare associated infection rates.

The report, Environmental Cleaning for the Prevention of Healthcare-Associated Infections (Technical Brief Number 22) details a systematic review of 80 studies that aimed to  determine the evidence base and comparative effectiveness of environmental cleaning methods and monitoring strategies of frequent touch surfaces in hospital rooms. The report concluded there was a lack of studies directly comparing cleaning methods and monitoring strategies, and calls upon the research community to undertake further research that:

·       Examines and compares emerging strategies (including ATP and UV light technologies).

·       Includes patient colonisation and infection rates as outcome measures.

·       Identifies surfaces in hospital rooms posing the greatest risk of pathogen transmission.

·       Examines factors that affect the real-world implementation of cleaning interventions (organizational culture, training, feedback).

An obvious omission to the report is that the value for money of any change to practice is not considered. Current health spending growth will not continue as it has. And infection prevention communities must think about the returns per dollar spent on new programmes.

Both effectiveness and cost-effectiveness evidence for a new ‘bundle’ approach to hospital cleaning will be generated by the REACH project. The effect on the transmission of healthcare associated infections (HAIs) in eleven Australian hospitals will be estimated and the value for money assessed.

The randomised controlled trial funded by the an NHMRC Partnership grant (GNT1076006) is led by QUT and The Wesley-St. Andrew’s Research Institute (WSARI) in conjunction with industry, policy and professional partners.

For more information about the REACH Project, please visit:  http://reach.cre-rhai.org.au/

The post originally appeared on the AusHSI Blog.

Regulatory fatigue

Last week, I was a visiting professor in the Department of Anesthesiology at Vanderbilt University. I must admit that I had some trepidation regarding spending a few days with anesthesiologists. I'm an internist, and like most internists, we stay clear of the OR. However, it turned out to be a great visit. I met with very creative, highly engaged physicians and scientists with whom I share a basic desire to improve the quality and safety of health care. We spoke the same language.

During a lively dinner conversation, the topic turned to The Joint Commission. And I learned that one of the dinner guests had just published a paper in Anesthesia and Analgesia on the The Joint Commission and regulatory fatigue. The paper focuses on accreditation "standards" that lack supporting evidence (some of which may actually lead to patient harm), and the cover art from the issue illustrates in a farcical way what most of us know all too well.

The authors and the journal should be commended, as it's rare to see individuals or organizations take on the almighty Joint Commission. In a previous job I was asked not to point out blatantly inaccurate statements about infection control made by on-site JC surveyors. Those of you who know me would probably guess that I did it anyway.

It's unfortunate that we are forced to play a cat and mouse game where the rules are never really articulated but violation of these invisible rules results in the infliction of great pain. There is an alternative to TJC, and 500 US hospitals are now being accredited by DNV. While I have no personal experience with DNV, I have discussed the DNV accreditation process with several individuals at hospitals using DNV. All were exuberant in their praise for the organization and its processes, which focus in a collaborative way on helping hospitals improve performance. The DNV website states that on-site surveys are "more of a routine check up on your success, not an epic investigation of your faults." Wow! What's not to like about that?

Trigger happy?

The University of Maryland group has just published two new papers on the safety of contact precautions. One is an analysis of the data from the BUGG study (published in CID), which was a multicenter study of ICU patients, and the other is a matched prospective cohort analysis at an academic medical center (published in ICHE).

Here’s a quick summary of the two papers:

The authors’ conclusions for both papers are essentially the same: concerns about the safety of contact precautions should not limit the implementation of contact precautions. One paper showed no difference in adverse events and the other paper showed that contact precautions was actually safer than not being in contact precautions, which I think is a counterintuitive finding for many of us. 

The problem that I have with both of these papers is the use of the IHI Global Trigger Tool (GTT) to determine the rates of adverse events. I have three concerns:

1. Are all of the events identified by the GTT causally linked to the exposure? For example, in the ICHE study, the strongest association was found for surgical events, and the association was highly counterintuitive: postoperative hemorrhage was found in 1/148 patients in contact precautions vs 12/148 patients not in contact precautions. Given what we know about contact precautions, particularly that it reduces healthcare worker visits, what could be the causal mechanism for a higher rate of post-operative hemorrhage in patients not in contact precautions? Is there a confounder at play here? There may very well be a causal mechanism but I’m hard pressed to think of one.
2. The IHI GTT only looks for errors of commission, not errors of omission, and it seems likely that errors of omission would occur more commonly when a barrier to care is implemented (contact precautions).
3. The IHI GTT sets a 20-minute time limit for the detection of errors when reviewing a patient chart whether the patient was hospitalized for 1 day or 100 days. In the ICHE study, the patients were matched on length of stay; however, I don’t think this resolves the problem. The GTT’s ability to detect error is time dependent. So when comparing two groups, if one group truly has a significantly higher rate of adverse events, a lower proportion of the events will be detected in the group that has more events, reducing the difference between the two groups. In effect we have surveillance bias.
   
   Even the IHI openly admits that this is an issue. Here’s a direct quote from the GTT manual:

The IHI Global Trigger Tool was never intended to identify all adverse events. Experienced reviewers familiar with the IHI Global Trigger Tool will identify almost all events greater than category E in a patient record that can be reviewed completely within the 20-minute time limit. Events in the E category of harm involve more judgment and at times are not as obvious, so these are less easily identified and may be missed. When the 20-minute time limit is enforced not all adverse events are expected to be identified.

In both of the papers, the 3 issues cited above are likely biasing towards the null, making contact precautions to appear to be safer than it is. So I continue to be concerned that contact precautions may result in less safe care. I think that most people in the hospital epidemiology community regard the University of Maryland researchers as some of the best methodologists in the field, and I certainly hold them in very high regard. Nonetheless, I’m curious about their love for the Global Trigger Tool, and hope that they share their views with us on this blog.