SIDP Position Statement on the Role of Antimicrobial Stewardship Pharmacists in the Use of Rapid Diagnostic Testing in Acute and Ambulatory Care

Preamble

Excessive antimicrobial use not only harms patients through enhanced risk for Clostridium difficile infections, antimicrobial resistance, and mortality, but also has negative implications for society.  Rapid molecular diagnostic technologies for infectious diseases have dramatically reduced the time to pathogen identification thus allowing for earlier cessation or ‘targeting’ of therapy to the most effective agent.  These technologies are not as impactful if they are implemented without a team to drive their utility.  Active intervention through antimicrobial stewardship programs (ASP) and guidance provided to clinicians through stewardship pharmacists are necessary to positively impact patient care.  This was demonstrated in a recent meta-analysis that showed a reduction in mortality with rapid diagnostics plus ASP compared to rapid diagnostics alone for bloodstream infections.¹  The Society of Infectious Disease Pharmacists supports ASP pharmacists as an essential component of rapid diagnostic technologies for the management of infectious diseases.

Collaboration with microbiology team

The inception of rapid diagnostic utilization at any facility requires interprofessional collaboration with microbiology laboratory personnel.  As with many other process implementations there are multiple phases to planning: pre-implementation, real-time use, and post-implementation.  In the pre-implementation planning phase, there must be coordination between the ASP pharmacist and microbiology to gauge the rapid molecular diagnostic needs of the hospital.  Factors that help determine technological needs of the hospital include, but are not limited to hospital bed size, patient acuity, hospital and community resistance patterns, and empiric antibiotic utilization.  Certain hospital-specific issues may warrant different types of technology for rapid molecular identification.  For example, hospitals with high rates of blood culture contamination and unnecessary use of vancomycin as a consequence may have clinical and economic benefits to rapidly distinguish between S. aureus and coagulase-negative staphylococci.  Additionally, the ASP pharmacist and microbiology must take inventory of resources to support real-time rapid diagnostic result reporting, including workflow changes for the microbiology lab personnel and the ASP pharmacist due to the volume of calls with positive results.  The unique training and knowledge-base of the ASP pharmacist in regards to antibiotic susceptibility testing and clinical utility of specific antibiotics creates a well-rounded team to coordinate actionable interventions based on these results.  The ASP pharmacist should work with the laboratory to obtain and analyze data from molecular diagnostic utilization (e.g. number of results per week). 

Communication with primary team

Effective communication between the microbiology laboratory and medical providers is key to ensure the information from these various technologies is utilized in an appropriate and effective manner. The ASP pharmacist plays a vital role in creating education for hospital providers to familiarize them with the new technology and how it might impact patient care. The ASP pharmacist also interacts with the providers at an individual patient level to encourage acting on the tests results. Additionally this individual should serve as a liaison between the microbiology laboratory and healthcare providers so that the interpretation of results are well understood and acted upon promptly in the absence of the ASP pharmacist’s individual recommendation.

Barriers to implementation and methods to overcome:

Implementing rapid diagnostic technology is not without barriers.  The primary barriers are a lack of trained personnel and funding for programs. While rapid diagnostic testing is highly reliable and becoming widely available, the tests remain costly and, depending on the setting, may not all yield improved outcomes. Without a known clinical demand and the appropriate infrastructure, hospitals will find it difficult to realize a full and worthwhile return on investment. The initial step in justifying rapid diagnostics involves collaboration between the ASP pharmacist and the clinical microbiology laboratory to identify and quantify the expected clinical and economic impact based on the targeted pathogen(s) local prevalence and resistance rates, number of patient cases, logistics, and the costs associated with the test. If a need exists, a communication plan for transmitting rapid testing results needs to be clearly mapped out and piloted to ensure improvement in patient care are attainable. Collaboration between the laboratory staff, information technology, clinical pharmacy, infection control, and the medical staff is essential to ensuring the identified opportunity translates to a change in clinical practice.

Quality metrics

An essential means of demonstrating value to leadership and providing analysis of opportunities for improvement as required by the Joint Commission for an ASP program is to identify metrics to assess the impact of rapid molecular diagnostics on patient care. Evaluating new technologies with metrics related to clinical outcomes may also prove beneficial in convincing providers of their value in order to increase buy-in and use of these results in real-time. A number of metrics have been used to evaluate the effects of rapid diagnostics. Included in these metrics are improvements in patient care, such as reduction in time to appropriate therapy and reduction in mortality.  Cost savings metrics should include direct cost savings and evaluation of reduced costs for infection control, pharmacy and reduction in additional laboratory tests.  In addition to direct cost savings, use of rapid diagnostics could be correlated with surrogate metrics, including reduced length of stay and reduced antibiotic consumption.¹  Hospitals should take into account their size and hospital resources when deciding on quality metrics to ensure optimal and safe use of this resource. Quality metrics are often measured during the post-implementation phase and should be periodically reassessed throughout the life of the program.

Continuing education

ASP pharmacists positively impact patient care through use of rapid diagnostic technologies for infectious diseases.  However, the field of rapid diagnostics is continuously changing with new methods on the horizon, thus continuing education courses focused on these technologies should be offered to all members of the ASP team, including clinical pharmacist in other specialty areas. The role of rapid diagnostic technologies, a review of rapid diagnostic tests currently used in ASP programs, and how to develop protocols for integrating tests into patient care activities and for responding to clinically significant results should be incorporated into continuing education courses and in ID PGY2 training curricula.^2,3

References:

1.      Timbrook TT, Morton JB, McConeghy KW, et al.  The Effect of Molecular Rapid Diagnostic Testing on Clinical Outcomes in Bloodstream Infections: A Systematic Review and Meta-analysis. Clin Infect Dis. 2017 Jan 1; 64: 15-23.

2.       Caliendo AM, Gilbert DN, Ginocchio CC, et al. Better Tests, Better Care: Improved Diagnostics for Infectious Diseases. Clin Infect Dis. 2013 Dec 1; 57(Suppl 3): S139-S170.

3.       Bauer AK, Perez KK, Forrest GN, et al. Review of Rapid Diagnostic Tests Used by Antimicrobial Stewardship Programs. Clin Infect Dis. 2014; 59(S3):S134-45.

Great job by the authors!  By no means was this an easy task.  

A few additional comments:

• It's never overtly stated that the ASP pharmacist should be the one directly receiving alerts from the RDT.  Not sure if this is something that SIDP wants to outright endorse.  Currently the position paper does not mention anything about who should be receiving the results.
  

Some additional references regarding stewardship involvement with RDTs, in addition to Timbrook's:

• Holtzman C, Whitney D, Barlam T, Miller NS. Assessment of impact of peptide nucleic acid fluorescence in situ hybridization for rapid identification of coagulase-negative staphylococci in the absence of antimicrobial stewardship intervention. J Clin Microbiol. 2011;49(4):1581-1582. doi: 10.1128/ JCM.02461-10.
• Cosgrove SE, Li DX, Tamma PD, et al. Use of PNA FISH for blood cultures growing Gram-positive cocci in chains without a concomitant antibiotic stewardship intervention does not improve time to appropriate antibiotic therapy. Diagn Microbiol. Infect Dis. 2016;86(1):86-92. doi: 10.1016/j.diagmicrobio. 2016.06.016.
• Frye AM, Baker CA, Rustvold DL, et al. Clinical impact of a real-time PCR assay for rapid identification of a staphylococcal bacteremia. J Clin Microbiol. 2012;50(1):127-133. doi: 10.1128/JCM.06169-11.
• Banarjee R, Teng CB, Cunningham SA, et al. Randomized trial of rapid multiplex polymerase chain reaction-based blood culture identification and susceptibility testing. Clin Infect Dis. 2015;61(7):1071-1080. doi: 10.1093/cid/civ447.
• MacVane SH, Nolte FS. Benefits of adding a rapid PCR-based blood culture identification panel to an established antimicrobial stewardship program. J Clin Microbiol. 2016;54(10):2455-2463. doi:10.1128/JCM.00996-16.

Michael Klepser wrote:

I did not see anything in the piece related to Ambulatory Care.  SIDP recently authors 4 papers that highlighted the use of RDTs and outpatient ASP.  I suggest referencing these papers and adding information pertaining to Ambulatory Care practice.

1. Gubbins PO, Klepser ME, Dering-Anderson AM, Bauer KA, Darin KM, Klepser S, Matthias KR, Scarsi K. Point-of-care testing for infectious diseases: Opportunities, barriers, and considerations in community pharmacy JAPhA. 2014;54:163-71.    
2. Gubbins PO, Klepser ME, Adams AJ, Jacobs DM, Percival KM, Tallman GB. Potential for Pharmacy-Public Health Collaborations Using Pharmacy-Based Point-of-Care Testing Services for Infectious Diseases. J Public Health Manag Pract. 2016. doi: 10.1097/PHH.0000000000000482.    
   
3. Dobson EL, Klepser ME, Pogue JM, Labreche MJ, Adams AJ, Gauthier TP, Turner RB, Su CP, Jacobs DM, Suda KJ; SIDP Community Pharmacy Antimicrobial Stewardship Task Force. Outpatient antibiotic stewardship: Interventions and opportunities. JAPhA. 2017. doi: 10.1016/j.japh.2017.03.014.
   
4. Klepser ME, Dobson EL, Pogue JM, Labreche MJ, Adams AJ, Gauthier TP, Turner RB, Su CP, Jacobs DM, Suda KJ; SIDP Community Pharmacy Antimicrobial Stewardship Task Force. A call to action for outpatient antibiotic stewardship. JAPhA. 2017. doi: 10.1016/j.japh.2017.03.013.