What’s New in the Patient Safety World


May 2009


While we try to avoid climbing on our soapbox to express our views on where we need to go in reforming our healthcare system, recently there have been several articles that deal with both quality and patient safety and highlight problems with our current healthcare system that need to be addressed in any reform effort. The articles address key issues in healthcare delivery (providing care in the most cost-effective venue, avoiding conflicts of interest, restoring the medical research enterprise to a more objective format, expanding the role of the FDA to better monitor drug safety after drug approval, and use of evidence-based practices that improve patient safety). Collectively, the elements in just these articles have the potential to save billions of dollars to our healthcare system. While universal healthcare coverage is something we must achieve, the potential savings from implementation of lessons in these articles is crucial for reform of our healthcare system to be successful.


·        Potentially Avoidable Admissions


·        IOM Report on Conflicts of Interest


·        Erythropoiesis-Stimulating Agents and Mortality


·        NQF Safe Practices for Better Healthcare



Potentially Avoidable Admissions



We’ve already been addressing in many columns reforms to the Medicare payment system that have addressed “never events” and “readmissions”. We think the next target is likely to be “avoidable admissions”. The Healthcare Cost and Utilization Project (HCUP) has just released its report on the frequency and costs of potentially preventable hospitalizations for 2006. Basically, potentially avoidable hospitalizations are a group of ambulatory care-sensitive conditions that, at least in theory, could be managed appropriately on the outpatient side so that hospitalization could be avoided. Of course, not all such admissions are preventable. For example, the risk of hospitalization for community-acquired pneumonia can be reduced by both influenza and pneumococcal vaccination and good management of underlying chronic conditions. But even previously healthy patients can get pneumonia severe enough to require hospitalization.


The HCUP study identified over 4 million hospitalizations in the potentially preventable category in 2006, responsible for over $30 billion of healthcare expenses. So even if only some of these admissions were preventable there is still considerable potential savings. The HCUP study showed that the rates of preventable hospitalizations were considerably higher for Medicare patients than for those with private insurance. Also, patients from poorer communities were much more likely to have preventable hospitalizations than those from wealthier communities.


Hospitals have little control over many of these admissions, unless the patients receive their primary ambulatory care in that hospital’s system. So hospitals should not be penalized for these potentially avoidable admissions. That is in contradistinction to the argument about hospital readmissions, where hospital activities may play a big role. So where would CMS and other payors look to save the dollars from? The most obvious way to get incentives aligned for all parties will be to encourage true integrated healthcare delivery systems in the future that would receive global budgets or full capitation. That way the primary care delivery system will be incentivized to avoid these potentially preventable admissions. It is issues like these that mandate we restructure our healthcare payment system to help rationalize our healthcare delivery system across the entire continuum.






H. Joanna Jiang, Ph.D., C. Allison Russo, M.P.H., and Marguerite L. Barrett, M.S. Nationwide Frequency and Costs of Potentially Preventable Hospitalizations, 2006. The Healthcare Cost and Utilization Project (HCUP). April 2009




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IOM Report on Conflicts of Interest


The Institute of Medicine (IOM) has finally released its report “Conflict of Interest in Medical Research, Education, and Practice”. One of the biggest reasons for rising healthcare costs is related to pharmaceutical and medical device costs. Some of the techniques used to increase demands for these products have been well publicized. Ghost writing (where the company basically writes the paper and gets someone else to agree to be the primary “author”), no matter how unethical, is a well-known phenomenon. Paying well-respected physicians or “opinion leaders” to speak at meetings and luncheons or dinners about the benefits of a drug or device (often for an “off-label” indication) is a tactic that often results in increased product sales or use. Negative studies (clinical trials that failed to show a beneficial effect of the drug or device compared to the control group) almost never get published. Until recently, the data from such negative studies was never available to any parties other than the industry sponsor (now clinical trial data is supposed to be posted publicly, though there is not yet full compliance with that). And in many cases, the researcher or the university has a financial interest in a study producing a positive outcome (eg. they may hold a patent on the drug, test, or device). Device manufacturers have paid large “consulting fees” to physicians who are in a position to get hospitals to purchase their devices. National standards and clinical guidelines are often written by panels on which there are individuals receiving considerable funding from industry. Industry also provides physicians a variety of “freebies” either directly or indirectly by sponsoring CME courses. And those of us who claim “those things don’t influence my practice” are in a state of denial. And the conflicts of interest do not just involve the physician community. Some organizations established to advocate for patients with a particular disease or conditon are often heavily subsidized by the companies who have the most to gain by promotion of their products. The conflicts go on and on. The result is that many of our patients receive treatments that ultimately are found to be either no more beneficial than a current treatment or in some cases actually harmful to them.


All these are examples noted in the IOM report. The report calls for substantial reform in how these conflicts of interest are both declared and managed. Our own feeling is that the only real way to avoid such conflicts of interest is to return research to financially disinterested parties. Whereas in the past most medical research was performed by academic medical centers and sponsored by NIH or other non-industry sponsors, now most research is sponsored and funded by the industry itself. So the government’s failure over the years to provide adequate research funding and oversight has really allowed medical research to be hijacked by the very parties likely to have conflicts of interest. Failure to adequately fund the national research endeavor thus has actually been one of the root causes of our rising healthcare costs.




Institute of Medicine. Conflict of Interest in Medical Research, Education, and

Practice. Report Brief • April 2009





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Erythropoiesis-Stimulating Agents and Mortality


Sometimes certain practices get incorporated into clinical practice without a solid evidence base. Only years later do we recognize that such practices may actually be harming patients. Erythropoiesis-stimulating agents are a prime example. The evidence base for using these agents in some conditions has been surprisingly weak. Yet they have become a mainstay in treatment of chronic kidney disease and chemotherapy-associated anemia. In the previous section we noted how some conflicts of interest may lead to excessive or unnecessary use of certain products. Well, economic incentives to providers have played a huge role in not only using erythropoiesis-stimulating agents in many conditions but also in using them in higher and higher doses. Direct-to-consumer advertising undoubtedly has also played a role in promoting their use.


Only in the last couple years did the possibility of an adverse effect of these agents on mortality become apparent. The practice of aiming for higher target hemoglobin levels came under fire when it was demonstrated that mortality was higher in groups randomized to higher hemoglobin targets (Phrommintikul et al 2007). Now a new meta-analysis of randomized controlled trials of erythropoiesis-stimulating agents in cancer patients (Bohlius et al 2009) has demonstrated higher mortality in those treated with erythropoiesis-stimulating agents and transfusions compared to those treated with transfusions alone. The higher mortality rates were seen in cancer patients whether or not they were being treated with chemotherapy and was seen across a variety of cancers and cancer treatments. The mortality rates were higher during the active treatment period and overall survival was also affected.


Admittedly, there may be benefits of such agents on quality of life. But we need to make sure we appropriately weigh those potential benefits against the risks.


And, again, the lesson here is that continued surveillance is needed long after initial FDA approval of drugs and devices. The failure of our system to effectively carry out that surveillance has often led to adverse outcomes for our patients and contributed to the rapidly rising costs of healthcare in our current system.





Phrommintikul A, SJ, M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. The Lancet 2007; 369: 381 - 388



Bohlius J, Schmidlin K, Brillant C, et al. Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. The Lancet 2009; 373: 1532 - 1542





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NQF Safe Practices for Better Healthcare


The National Quality Forum (NQF) has issued its 2009 Update to its Safe Practices for Better Healthcare. The original set of safe practices was developed in 2003 and updated in 2006. The current update adds 7 new practices to the set and consolidates several others. Each of the previous practices is also updated where new evidence-based practices have become available.


Each safe practice is discussed in a chapter in the report and there is a discussion of the nature and scope of the problem, the evidence base, the potential economic impact, the settings to which the practice is applicable (though most of the practices apply to all healthcare settings), the appropriate monitoring and measurement strategies, the recommended practices, and the areas for further research.


The report comes in a paperback version for $89.99. It also is available in a downloadable pdf file for $29.99. We prefer the latter – not only is it less expensive but you can easily use the search capabilities to find specific details.


Use of practices that promote patient safety not only benefits our healthcare system in terms of patient outcomes and satisfaction but has a huge potential economic savings to the healthcare system as well.





NQF. Safe Practices for Better Healthcare - 2009 Update A Consensus Report. NQF.  March 2009





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