Mr. McAllister is a health-systems consultant based in Chapel Hill, North Carolina.
Several pharmacist colleagues were discussing the USP 797 sterile compounding regulation and the challenges of implementation in order to comply with the Joint Commission standards. One of the discussion participants was a pharmacy resident who asked why a particular standard had been created. Several of us responded to the question with our assumptions and anecdotes that seemed germane to the issue.
The resident seemed satisfied with the cumulative answer, and the discussion proceeded to strategies to resolve the issue for that particular hospital.
I made a note to myself and revisited the issue and concluded that we really had not answered the resident’s question with supporting data. I began an online search about the issue, and despite numerous articles and even some published research related to the issue and the standard, none of the data in the public domain would pass as evidence-based research with the appropriate controls and scientific rigor that we would expect to evaluate a new drug for formulary addition.
I am not picking on the USP 797 regulation or the Joint Commission standards, both of which have undoubtedly helped improve health care and patient safety. Like other health care reform initiatives, the regulation and standards are well-intentioned expectations developed by incredibly bright and trusted thought leaders from many disciplines. New regulations and standards result in a myriad of changes, frequently requiring reallocation of resources, including staff, if not additional resources.
Unfortunately, these changes sometimes require that other programs or services are eliminated or substantively amended, without regard to relative value. Progress through change is often a very good thing, but given the increasing complexity of health care delivery, the diversity among organized health care settings, and these tough financial times for everyone, I suggest that we consider all processes of reform to ensure appropriate scientific rigor as an integral part of future regulatory development or reform processes.
I am old enough to remember when the American Society of Health- System Pharmacists (ASHP) used to promulgate various “standards.” Our collective good fortune is that ASHP leaders, including staff, realized that ASHP should be developing guidelines on various issues which individual hospitals or health systems could use in the development of policies that add value to patient care processes. I was not part of that philosophical shift, but I suspect that ASHP recognized that although these guideline documents were developed with considerable input from thought leaders, staff, and the membership (through the House of Delegates oversight processes), they were not necessarily evidence-based, especially for diverse practice settings. Their adoption or application by organizations should be based on their needs and review of their data.
In President Barack Obama’s “Plan for a Healthy America” (www. barackobama.com), one of the basic strategies to lower health care costs and make high-quality health care available for everyone calls for increased investment in “comparative effectiveness reviews and research.” Whereas at first glance this may be encouraging, the description of the initiative reflects a plan to make decisions using information “…developed by reviewing existing literature, analyzing electronic health care data, and conducting simple, real-world studies of new technologies.” The statement goes on to describe intentions “to establish an institute to guide reviews and research on comparative effectiveness...”
It seems to me that we already have plenty of bureaucratic infrastructure focused on data review and analysis. I would like to see these funds granted to researchers in diverse practice settings that perform well-controlled comparative trials focused on targeted federal and state objectives so that similar organizations can use and apply the findings to their institutions. What do you think?
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