ASPs: Who is smarter, the consultant or the curbside?
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The Infectious Diseases Society of America has advocated for the implementation of antimicrobial stewardship programs (ASPs) in every hospital. This year, CMS, under rule 3346-F, agreed, and now requires that even previously exempt critical access hospitals implement an ASP. CMS is vague on what an ASP is or means and states: “For the implementation of antibiotic stewardship programs, guidance is available from several organizations, including IDSA, [Society for Healthcare Epidemiology of America (SHEA)], American Society for Health System Pharmacists (ASHP) and CDC.” The documents issued by ASHP and CDC are not true guidelines. Essentially, CMS leans heavily on the joint IDSA/SHEA guidelines, first published in 2007 and updated in 2016.
In 2007, IDSA and SHEA recommended that an ASP consist of an ID doctor, a pharmacist with some ID training, a clinical microbiologist, an information technology specialist, an infection control professional and a hospital epidemiologist.
In 2016, IDSA and SHEA did not re-address ASP structure but updated the “elements” of an ASP. However, only one of the 28 elements — prior authorization and/or prospective audit and feedback — restrict or limit antibiotic use. The difference between these two approaches is that the latter allows every antibiotic to be, at least, started. The guidelines state, “We recommend preauthorization and/or prospective audit and feedback over no such interventions (strong recommendation, moderate-quality evidence).” In my view, IDSA and SHEA were generous to call the evidence “moderate-quality.” Several cited “studies” were not studies at all. The clinical trials used retrospective controls and were small. The interventions varied greatly from ASP to ASP. Regardless of the degree of the evidence’s quality, none of the cited studies showed an ASP was safe and effective when the ASP oversaw and regulated a treating ID doctor’s orders.
Despite IDSA’s 2007 guidelines recommending large, multidisciplinary ASP teams, most ASPs consist of a pharmacist and an overseeing ID doc. I have spoken to several ASP ID docs, including those who oversee me. The ASP ID docs admittedly rely heavily upon the pharmacist’s review and opinion. The pharmacists, of course, simply review the chart and, in fact, rely on the ID consultant’s notes. The ASP team doesn’t interview or examine the patient, doesn’t talk to the treating doctors or nurses, doesn’t review the radiologic images, and doesn’t review the patient’s prior medical records. ASPs are essentially curbside consults, performed by a pharmacist via a chart review.
Most or many ASPs now have the authority to block, in real time, a treating ID doctor’s prescription for an antibiotic. When an ASP team consisting of a pharmacist and another ID doctor prevents me from using my first-line antibiotic regimen, I have to use a second-line regimen. This creates new moral and legal issues. First, am I obliged ethically to inform the patient and family that the hospital is forcing me to use a second-line regimen? Second, I chose the first-line regimen because the second-line regimen is more toxic and/or less appropriate for the situation. Who is legally responsible if the patient does poorly on the second-line regimen or develops an adverse effect solely attributable to one of the second-line agents? If I am forced to use amikacin to cover carbapenem-resistant Enterobacteriaceae in high-risk patients and the patient develops vestibular disease, which can happen after a single dose, am I responsible, even though I prescribed Avycaz (ceftazidime and avibactam, Allergan) for the patient?
We have some recent literature proving the benefits of ID consults. These studies were done without interference by an ASP. It demeans our profession and demoralizes its practitioners to have a third party with superficial knowledge of the patient block your order. Either ID doctors are needed — or we are not.
These ASPs pit ID doc against ID doc. I order an antibiotic, and a colleague blocks it. My colleague doesn’t know the patient as well as I do, may not know the relevant literature as well as I do, has spent 1/50th of the time I did in reaching my decision and, at most, read my consult and progress notes to gather information about the patient. Now, even after I presented my detailed case for my antibiotic choice, my colleague has still blocked my order. What is my role in this case? Am I the ASP team’s ID fellow? We cannot have some ID doctors who are more equal than the others. Do I think there are differences in the knowledge bases, work ethic and clinical expertise among ID doctors? Of course I do. However, I would never advocate for a program wherein I decide what is best for board-certified ID doctors’ patients.
Internal medicine residents hear ID attendings fuming about ASP interventions. This situation certainly doesn’t improve our chances of increasing fellowship applications. I personally have advised several pre-med or medical students against going into ID, including two of my children, who would be third-generation ID docs.
I have called on IDSA to make a statement against ASPs of this kind and was advised to get along better with the ID doctors who work with the ASP. Actually, I do get along with both, but they are paid to say “no,” not “yes.” Another IDSA official sent me his ASP study, which showed positive results. I pointed out that his study recommended ID consults; it did not oversee and regulate patients being managed by ID doctors. No study has. In essence, IDSA tacitly supports ASPs of this kind. Yet, no other subspecialty similarly oversees its practitioners in real time.
Back to the beginning: The data on ASPs are not strong. The studies are small, apply different forms of stewardship and essentially prove that non-ID docs don’t know diddly about antibiotics. Regardless, the data on ASPs, which oversee, regulate and block ID doctors’ orders, simply do not exist. The IDSA can either be for or against evidence-based medicine; it cannot be for evidence-based medicine in some situations and not in others. I am confident that blocking the treating ID doctor’s antibiotic order is harmful. I am certain when my antibiotic orders have been blocked, the ASP’s intervention decreased the patient’s chances for a good outcome. Some ID docs may disagree, because these ID docs know more than the other ID docs. In doing so, these ASP docs are saying that we do not need to talk to the patient, examine the patient, review the prior records or review the images to reach a decision on antibiotic treatment. If that’s true, then we need to do away with infectious diseases as a medical specialty because these especially smart ID docs can make the correct decision after hearing a 3-minute presentation done by a pharmacist.
I will close with a question: Why would anyone be stupid enough to do a 2-year fellowship after a 3-year residency after 4 years of medical school, then study hard for board certification and then again for recertification, only to have her/his antibiotic orders blocked by those with the same or lesser training and lesser information about the patient?
Editor's note: To read the IDSA’s response, click here.
- References:
- Barlam TF, et al. Clin Infect Dis. 2016;doi:10.1093/cid/ciw118.
- CMS. Omnibus burden reduction (conditions of participation) final rule CMS-3346-F. https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-reduction-conditions-participation-final-rule-cms-3346-f. Accessed January 23, 2020.
- Dellit TH, et al. Clin Infect Dis. 2016;doi:10.1086/510393.
- Federal Register. Medicare and Medicaid programs; regulatory provisions to promote program efficiency, transparency, and burden reduction; fire safety requirements for certain dialysis facilities; hospital and critical access hospital (CAH) changes to promote innovation, flexibility, and improvement in patient care. https://www.federalregister.gov/documents/2019/09/30/2019-20736/medicare-and-medicaid-programs-regulatory-provisions-to-promote-program-efficiency-transparency-and. Accessed January 23, 2020.
- For more information:
- Stephen M. Smith, MD, is the founder and medical director of the Smith Center for Infectious Diseases and Urban Health in East Orange, New Jersey, and an Infectious Disease News Editorial Board Member.
Disclosure: Smith reports no relevant financial disclosures.
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