Not laws. Not even rules. We just approach them that way in medicine.
Of course, guidelines have their place. It’s a significant undertaking to get a bunch of experts in a room together (or perhaps on a Zoom call these days…) and have them review literature on a topic pretty exhaustively. Then you have to get everyone to come to a consensus on recommendations that are as evidence-based as possible and applicable to as many patients as possible. It’s a painstaking, time-consuming process, and, given the amount of expert analysis that goes into the finished product, guidelines are rightfully treated with deference. Like all things in medicine, however, guidelines have their limits, and recognizing those limits can improve our collective quality of patient care.
For starters, guidelines are always behind the times. The creation process takes months and sometimes years to account for the sheer volume of medical literature summarized in one document. By the time you get a finished product, some of the information used to make treatment recommendations may have been supplanted by newer, more compelling evidence. Brand new treatments may be left out altogether, since these expert panels have to draw the line somewhere amidst the never-ending deluge of medical publications.
A good example of this is the most recent C. difficile guidelines, compiled in 2017 and published in February of 2018. Bezlotoxumab (Zinplava) – a monoclonal antibody against C. difficile’s toxin B – had just been approved for adjunctive treatment of C diff infection in October of 2016. However, some of the more compelling studies demonstrating its clinical efficacy were not published until 2017 and later, so bezlotoxumab ultimately was not included in the treatment guidelines.
Personally, I’ve had a lot of successes with adding bezlotoxumab to primary therapy for recurrent C diff. No, I don’t have a financial stake in the drug, but I’ve found it to be accessible, well-tolerated and effective. Had I dug my heels in and said that I would not prescribe anything that wasn’t guideline-driven, some of my patients might have suffered avoidable C diff recurrences.
The other big problem with guidelines is that they can’t account for all the nuance of treating the particular patient in front of you. It’s pretty hard to make a sweeping recommendation that applies to absolutely everyone with a certain medical condition. The scenario that comes to mind here is MRSA endocarditis from injecting drugs. IDSA guidelines say to use 6 weeks of IV vancomycin or IV daptomycin to treat MRSA endocarditis. Period. But we all know that adhering to this particular guideline can be challenging when you have a young, otherwise healthy patient who is feeling better and threatening to leave AMA by the end of week 2 in the hospital.
If we adhere strictly to the guidelines in this situation, we’re stuck with several unattractive options: 1) keep encouraging/begging the patient to stick it out in the hospital for the whole 6 weeks; 2) discharge the patient with an indwelling line and hope they follow through; 3) see how long the patient is willing to come into an infusion center every day for a peripheral IV and a dose of daptomycin or 4) play hardball and tell them they don’t get the full course of treatment if they leave AMA. Personally, I like to operate outside the guidelines and go with option 5 here: ask the patient to stay as long as they possibly can, then, once they’re getting antsy, give them a dose of oritavancin (Orbactiv) and send them on their way.
For those of you not familiar with oritavancin, it’s a glycopeptide antibiotic in the same family as vancomycin. Again, I have no financial stake in the drug, but it’s an attractive option for several reasons. First, oritavancin is incredibly long-acting with a half-life of about 245 hours. A single dose can maintain therapeutic serum concentrations for four weeks or longer. Second, it has three simultaneous mechanisms of action, making resistance among Gram positives almost non-existent. Lastly, aside from the single two- to three-hour infusion period, dosing is easy. It’s generally very well-tolerated with no need for ongoing monitoring once patients have completed the infusion.
As you might guess, however, oritavancin is not currently approved to treat any MRSA infection other than skin and soft tissue. We have plenty of case series and anecdotal evidence to show that it works, but I imagine it’s unlikely to make it into the endocarditis treatment guidelines any time soon. Yet this sounds like a perfect solution for treating patients who might misuse a PICC line or fail to follow up for monitoring. (Incidentally, dalbavancin has a lot of the same advantages – oritavancin gets the nod because it’s cheaper.)
I could envision a time in the not-too-distant future in which most, if not all Staph aureus bacteremias get treated with a drug like oritavancin on admission. Patients would probably still stay a few days to ensure that the bacteremia cleared and that there were no metastatic complications, but if they decide to skip out, well…they’ve already completed treatment. Granted, this approach will require more testing and validation before becoming widely accepted. My point is that we already have patients who could benefit from a breakthrough treatment that probably won’t be included in IDSA guidelines for years to come.
We should respect the guidelines for the time and expertise they embody. Just don’t be afraid to venture outside their recommendations when the situation calls for it.