John Parkinson

Antimicrobial resistance (AMR) is a slow-moving train that is picking up steam and in its path are all patients battling bacterial infections. AMR is a multifactorial problem that includes many aspects, and potentially chief among them is the missing communication and disconnect with the public, who do not understand the nature of how it happens nor the consequences of the misuse of antibiotics.

One of the disconnects is the public’s lack of responsibility in the usage of antibiotics and AMR. While the lay population understands the potential problem theoretically, in practice, nearly half of people polled don’t know their actions can lead to resistance. In a poll conducted by the Kaiser Family Foundation, it was found that 67% of respondents were aware of the negative implications when overusing antibiotics, which could lead to patients having to take stronger therapies, and about 6 in 10 saying it will lead to longer lasting and more dangerous bacterial infections (63%) and an increasing amount of bacteria resistance to antibiotics (62%). However, a larger number of people believe the responsibility of protecting people from resistance belongs with drug companies and health care providers.

In the same poll, 45% of respondents say they have not taken their antibiotics as prescribed by their clinician, which can, of course, lead to resistance. 

One of the issues on the clinicians’ side has been in dentistry. Dentists have often prescribed antibiotics for prophylaxis purposes for patients undergoing surgical procedures. In the past, there were concerns over bacterial endocarditis in patients with heart issues who were given antibiotics to protect against this. However, newer studies around this topic have shifted the need for antibiotics in these patients. In a 2022 paper, Rutherford et al noted that “Guidance by the National Institute for Health and Care Excellence (NICE) in England and Wales states that antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures.”

In trying to reduce issues associated with antibiotic prescribing practices, Debra Goff, PharmD, a professor of pharmacy practice at The Ohio State University Wexner Medical Center, has been studying the subject of dentistry and antimicrobial stewardship for several years. She has become an advocate for the field and teaches dentists to understand fully the nuances of stewardship and how antimicrobial prescribing practices have changed.

“The [Centers for Disease Control and Prevention] published a great study that said, ‘25 million prescriptions a year are prescribed by dentists.’ But, when I looked into the details of that, that only represents general dentists working in the VA health care system,” said Goff, in an interview with 

. “I'm working with private practice dentists, which represent 80% of dentists in the United States, and the specialists, the oral surgeons, the periodontists, and the endodontists who need antibiotics… they prescribe a phenomenal volume of antibiotics. Some of them are necessary, but a lot of them [are not]. And the durations they're using are the old football scores—10 and 14 days, and they can do better. There's no evidence to support those long durations.”

She says dentists have largely been receptive to her presentations. “It's been so fun teaching them simple concepts of how they can be a steward, and they are helping me spread this message all across the United States,” Goff said. She has educated 3000 private practice dentists to date and continues to do so.
To help the public better understand the importance of this issue, and providing clinicians with a call to arms, she wrote an 

 issue earlier this year, describing antibiotics as the sheep, the pharmacists and physician stewards as the dogs, and that the stewards needed to protect new antibiotics from the wolf, which is, of course, antimicrobial resistance.
“We have to be that herding dog that rallies for our patients, protecting them from antibiotic resistance,” Goff said.

These shortcomings don’t stop the AMR train’s approach. In fact, it is expected that the problem of AMR will grow exponentially, and with it will come greater mortality. A few months back, a study published in 

 looked at mortality associated with AMR from the present day up to the year 2050, with an estimation of the number of deaths in the next 25 years. This modeling study predicted that more than 39 million people could die from AMR globally in that time.

According to the investigators, more than 1 million people died each year because of AMR between 1990 and 2021. The study also estimates 1.91 million people could potentially die as a direct result of AMR in 2050, an increase of almost 70% per year compared with 2022. Over the same period, the number of deaths in which AMR bacteria play a role will increase by almost 75% from 4.71 million to 8.22 million per year.

A Personal Tragedy Grows into a Professional Mission

Diane Shader Smith is a publicist, and didn’t realize the magnitude of AMR until after her daughter Mallory’s death. Her daughter given a diagnosis of cystic fibrosis (CF) when she was 3 years old, explained Shader Smith, but it did not become problematic until the pathogen 

 was found in her lungs when she was 12 years old.

When people with CF become colonized with a bacteria such as 

, they are often put in a situation where it becomes a revolving door of medical encounters including hospitalizations, lung treatments, and antibiotic therapy. Unfortunately, antibiotic treatment can see diminishing returns as previously effective therapies are no longer working against the bacteria and a greater antimicrobial resistance is seen against a pathogen that never leaves the lungs.

Through the years, Mallory had been hospitalized to treat infections and, eventually, she became a candidate for a double-lung transplant. She had a successful surgery, but even with new lungs, the pathogen was back and sadly, Mallory succumbed to AMR at the age of 25.

Despite a growing spotlight around AMR, Shader Smith says it is hard for everyone to see this as one major issue. She launched the 

, which allows people to tell their individual medical stories about AMR.

“We're trying to push the global AMR diary as a way to get people to engage with the stories—to connect. But it's challenging because it's an amorphous problem that people don't really understand,” Diane Shader Smith said in an interview with 

Since getting involved in advocacy, she has given hundreds of presentations to different walks of life to everyone—from high school kids to grandparents—to let them know the scope and severity of the problem. Along with her talks, she has been involved in getting Mallory’s memoir, 

, published after her death, and a documentary with the same name about her daughter’s experience.

And while some people are more vulnerable to infections that can lead to resistance including those who are immunocompromised and seniors, Shader Smith makes the point everyone is vulnerable.

“It can strike anyone, anywhere,” Shader Smith said.It isn't just a problem for people like Mallory who had CF or someone with cancer, although those who have health conditions with compromised immune systems might be more at risk, and those in underserved communities are at higher risk, but the average person walking down the street could take a fall, cut their knee, and bacteria that's either in the hospital or in the community, can get into their system and cause them to be septic. I've met many people who have lost their lives or lost their limbs because of resistant bacteria, and they were perfectly healthy to begin with.”

Despite the daunting prognostications, large systemic changes may reduce resistance. One of the major issue of antibiotics is the supply side and the need for more therapies; however, the development of them has inherent challenges such as costs, time to develop them, smaller biopharmaceutical companies involvement—as opposed to larger companies—and quick resistance to newer antibiotics, as typically, they become resistant to evolving pathogens just a few years after introduction of them into the market.
In trying to combat the development issue, there is a prospective bill in Congress called the Pasteur Act. The bill has been in Congress for a few years now, and it authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs, provides $6 billion over 10 years in appropriations for activities under the bill, and contains other related provisions.

 Last year, Senators Michael Bennet (D-CO) and Todd Young (R-IN) and Representatives Drew Ferguson (R-GA) and Scott Peters (D-CA), 

reintroduced the Pasteur Act in Congress.

 The bill was initially introduced in Congress by Bennet and Young in September 2020; the pair, along with Representatives Mike Doyle (D-PA) and Ferguson, then reintroduced the bill in June 2021.

After the bill’s reintroduction last year, 5 national organizations—the Biotechnology Innovation Organization, the Cystic Fibrosis Foundation, the Infectious Diseases Society of America (IDSA), the Partnership to Fight Infectious Disease, and The Pew Charitable Trusts—issued a statement on the topic. “Antimicrobial resistance is not a partisan issue. It is an increasingly challenging public health emergency that reverberates far beyond just healthcare settings. Every 15 minutes, a person in the United States dies from an infection resistant to treatment with existing antimicrobial drugs. This means that since PASTEUR’s last introduction on June 16, 2021, more than 64,000 Americans have died because they did not have adequate medications to treat their infections,” part of the statement read.

Amanda Jezek, senior vice president for Public Policy and Government Relations at IDSA does believe the Pasteur Act will pass and says it is better to do so now than deal with the consequences of increased mortality rates and the inability to perform procedures due to concerns over AMR. “I think it has to; the stakes are too high,” said Jezek, in an interview with 

. “Right now, we are trying to convince Congress to do the right thing and pass this while we have a little bit of lead time to protect modern medicine.”

Jezek says that along with being a major supporter of the Congressional bill, IDSA is involved in other AMR-related activities, including the US national plan to address AMR. They were also involved in the United Nations meeting last summer, which looked at AMR and a One Health approach. The United Nations and its member nations met back in August to address AMR.

Lori Russell, senior vice president for Public and Government Affairs and Compliance, 

, attended the UN and believes there were productive talks around reducing AMR. Her role within her diagnostics company is to lead initiatives to promote the value of diagnostics and work with stakeholders, including policy makers and industry leaders, focusing on advancing public health through diagnostics.

“I had the privilege of attending the [United Nations] high level meeting where we were able to provide an intervention highlighting the critical role of diagnostics in addressing the AMR crisis and the need for national action plans to include diagnostics as a pillar of their stewardship strategies,” she said in an interview with 

As with any big world problem with complexities associated with it, it is going to take consensus building and various approaches at the ground level up to systemic changes to slow down the AMR train or look to derail it. From the frontline clinicians to patients, to infectious disease organizations, up to country members of the UN—everyone is an interested stakeholder in this fight. The question remains: will enough be done to reduce resistance and stop or slow down a train that will affect millions of people in the coming years? 

Cailey Muñana, Ashley Kirzinger, Lunna Lopes, Liz Hamel, and Mollyann BrodieData Note: Public Awareness Around Antibiotic Resistance. Kaiser Family Foundation.

Rutherford SJ, Glenny AM, Roberts G, Hooper L, Worthington HV. Antibiotic prophylaxis for preventing bacterial endocarditis following dental procedures. 

. 2022;5(5):CD003813. Published 2022 May 10. doi:10.1002/14651858.CD003813.pub5
Naghavi, M, et al. Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050. 

. September 16, 2024. doi: 10.1016/S0140-6736(24)01867-1

Summary: S.1355 — 118th Congress (2023-2024). Congress.gov. Accessed September 5, 2024. https://www.congress.gov/bill/118th-congress/senate-bill/1355

Articles

Antimicrobial resistance (AMR) is a growing global health threat exacerbated by public misunderstanding and misuse of antibiotics. Despite awareness of AMR's dangers, many individuals fail to adhere to prescribed antibiotic regimens, contributing to resistance. Dentists' overprescription of antibiotics is highlighted as a significant issue, with efforts underway to educate them on antimicrobial stewardship. The potential impact of AMR is severe, with millions of deaths projected by 2050. Systemic changes, including legislative efforts like the Pasteur Act, are crucial to combat AMR, requiring collaboration across healthcare, policy, and global organizations.

Resistance is expected to worsen significantly, but can a combination of both ground-level clinician stewardship actions as well as systemic reforms such as the Pasteur Act at least slow down the train? 

The Slow-Moving Antimicrobial Resistance Train is Picking-up Morbidity and Mortality Steam

For the sickest of patients who might be battling multidrug-resistant, gram-negative bacterial infections—particularly those with comorbidities—time is of the essence to get to a diagnosis and optimal treatment. Yet, medical science is designed to move deliberately—to do no harm—and to practice within the economic realities presented to providers. However, this current treatment paradigm might be set up to continue and proliferate the antimicrobial resistance (AMR) crisis, especially in the aforementioned patient population as they continue to cycle through the health care system repeatedly and have multiple treatments with antibiotics.

Current clinical practice is set up to use first-line, well-established therapies, so this often means utilizing older therapies. Add to this the newer concept of antimicrobial stewardship, and you may have clinicians who may be reluctant to use newer antibiotics for a few reasons including being a good antimicrobial steward, or there may not be enough study data to fully understand adverse effects and the efficacy of the newer antimicrobials.

In addition, patients in some long-term care settings may be delayed in getting diagnosed, and often patients can be given broad-spectrum antibiotics that may be limited in efficacy and leads to switching antibiotics and more exposure to these therapies and the possibility of AMR.

“We see people with repeated multiple antibiotic exposures, multiple infections. Even if it started out as maybe a staph infection or was 

 over time with repeat infections and repeat courses of antibiotics, those [patients] are at greatest risk for a carbapenem-resistant pathogen,” Tom Lodise, PharmD, PhD, professor at the Albany College of Pharmacy and Health Sciences, and clinical pharmacy specialist at the Stratton VA Medical Center in Albany, New York, told 

. “These sort of [case scenarios] is where I think we need to be more aggressive…every day matters in the gram-negative space. We think about antibiotic stewardship—our fundamental pillar is getting it right up front. Despite this, we still find in over half of the patients with an antibiotic resistant gram-negative infection, they do not receive an active drug for the first 48 - 72 hours.”

Lodise says the time-to treatment concept which involves getting patients the diagnosis and on the correct antibiotic in a timely manner can be beneficial to patient outcomes.

“Every day matters with our gram-negative infections, and the longer we delay, there's substantial increases in both morbidity and mortality,” Lodise said.

Rapid diagnostics is an area where the advancement of technology has vastly improved and is becoming an emerging part of medicine. As the name suggests, they can quickly reveal pathogens and viruses.

“Such assays have relatively short performance times, provide results to inform clinical decision making, and enable management at the point-of-care (POC),” wrote authors of the Centers for Disease Control and Prevention’s (CDC) Yellow Book.

However, there are some inherent challenges. For starters, laboratories in medical settings vary. Whereas in a large teaching hospital these tests may be available and there may be adequate staffing of laboratory professionals to conduct them, in many smaller community or mid-sized hospitals there may be limited resources to have such tests and personnel.

The laboratory field itself has become even more crucial, especially as the number of tests has increased and the diagnostics have become more complex. According to the CDC, there are more than 14 billion clinical lab tests performed in the US annually.

 If one were to also consider the millions of COVID-19 tests administered over the last few years, this has put an enormous strain on medical laboratory professionals.

While the need for such vital personnel increases, the field has seen shortfalls.

“With the projected increases in the need for medical laboratory professionals, and the current high vacancy rates, the profession is suffering from a workforce shortage that is approaching crisis levels for medical laboratory technicians, medical laboratory scientists, histotechnicians and histotechnologists,” the American Society for Clinical Laboratory Science (ASCLS) wrote in a prior statement.

ASCLS stated some of the reasons for the shortages includes retirements, an increased demand for lab services, changes in the practice of clinical laboratory science due to technology advances, and vacancies that exceed the number of graduates.

“Our professionals are critical. We are often not thought of in direct patient care, because we're laboratory based, diagnostic detective types," Rodney E. Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSc regents’ professor, Texas State University, university distinguished chair & professor, Clinical Laboratory Science, told 

. “One of the things I like to tell people is that we’re the mechanics and the ground crew for that airplane you're getting on. You don't think about this every day, but you better hope they're alert, and they're doing their job.”

The FDA has approved novel gram-negative antibiotics in recent years, but they have not necessarily seen the adoption or uptake of use that therapies in other areas of care might.

Sameer S. Kadri, MD, MS, FIDSA, intensivist and head, Clinical Epidemiology Section, Critical Care Medicine Department, National Institutes of Health Clinical Center, and a team of investigators looked at the utilization of novel, gram-negative antibiotics in US hospitals, and he says that medical providers appear to go the route of prescribing well-established antibiotics and even using ones that could be potentially toxic.

“I think there was a degree of comfort level with some of the older agents, even though they were toxic, when there was no agent available as an alternative. Now that there are agents available, I think, there is evidence in the form of trials that have led to the approval of these novel agents,” Kadri told 

. “But you know, there's not that much representation of patients with highly-resistant pathogens in some of those trials, and that does result in a little bit of uneasiness around whether the evidence is generalizable to the patients with highly-resistant pathogens.”

This may present scenarios where newer and novel antibiotics might be sitting on the pharmacy shelves. Kadri said one of the key takeaways from the study was a potential strategy to overcome this reticence of clinicians to prescribe these newer agents.

“I think an important factor is that hospitals that opted for testing susceptibility against these novel agents tended to [have] greater use of these novel agents,” Kadri said. “It's a reminder that there needs to be wider implementation of susceptibility testing capabilities across the country against novel agents that are released, so that clinicians like myself feel confident that the drug that we're using in our patients actually works.”

Another potential strategy to address the greater adoption of new or novel antibiotics is the prospective Pasteur Act. Ideally, this act would entice pharmaceutical companies to develop more antibiotics by establishing an innovative payment contract (subscription model) where the federal government invests in highly novel antibiotics and antifungals through installment payments in exchange for free access to developers’ drugs in government programs once available.

The Pasteur Act was initially introduced in Congress in 2020, then reintroduced in both 2021 and earlier this year. When it was reintroduced back in April, 5 national organizations—the Biotechnology Innovation Organization, the Cystic Fibrosis Foundation, IDSA, the Partnership to Fight Infectious Disease, and The Pew Charitable Trusts—issued a joint statement on the topic.

“Antimicrobial resistance is not a partisan issue. It is an increasingly challenging public health emergency that reverberates far beyond just health care settings. Every 15 minutes, a person in the United States dies from an infection resistant to treatment with existing antimicrobial drugs. This means that since PASTEUR’s last introduction on June 16, 2021, more than 64,000 Americans have died because they did not have adequate medications to treat their infections,” the statement read.

Can We Change the Diagnostic and Treatment Paradigm?

The US is well-positioned and responsive to public health emergencies. We just witnessed this with the COVID-19 pandemic. Yes, missteps occurred—but in a public health emergency with a fluid, ever-changing situation with emerging variants to contend with, the country did its best to respond to it.

However, addressing slow-moving, serious issues where long-term planning is warranted is not something well-considered or brought to the forefront in American public health. Yes, there are public health officials thinking about these things, but a clarion call has not been heeded to address how we need to be thinking about the rise and severity of antimicrobial resistance.

Right now, all these challenges of limited laboratory professionals, slow adoption of newer antibiotics, and possibly an outdated treatment paradigm seem separate, but in reality, putting the pieces of the puzzle together can make the treatment pathway for patients with AMR infections more comprehensive.

The addition of susceptibility testing, the increase in the number of laboratory professionals, and the passage of the Pasteur Act may all be steps towards creating new treatment pathways and lead to better outcomes.

The question remains: should these problems be resolved with a larger public health initiative bringing it altogether, or can they come together organically and medical science evolve to address these issues without government involvement?

Rapid Diagnostic Tests for Infectious Diseases CDC Yellow Book 2024. CDC. Last reviewed May 1, 2023. Accessed December 18, 2023. https://wwwnc.cdc.gov/travel/yellowbook/2024/posttravel-evaluation/rapid-diagnostic-tests-for-infectious-diseases#:~:text=

Clinical Standardized Programs. CDC. Last reviewed March 15, 2023. Accessed December 19, 2023. https://www.cdc.gov/labstandards/csp/index.html#:~:text=In%20the%20United%20States%2C%20approximately,Amendments%20(CLIA)%2Dcertified%20laboratories

Addressing the Clinical Laboratory Workforce Shortage. ASCLS. Accessed December 19, 2023. https://ascls.org/addressing-the-clinical-laboratory-workforce-shortage/

The current treatment paradigm might need to evolve to adjust to rapid diagnostics and narrowing down the antibiotics to aid in optimal outcomes for sicker patients with gram-negative infections.

Multidrug Resistant Infections: Is the Clinical Infection Treatment Pathway Outdated?

Credit: US Centers for Disease Control and Prevention

This article was originally published in ContagionLive.

The US Centers for Disease Control and Prevention (CDC) has announced recommendations for screening and testing for hepatitis B virus (HBV), calling for all adults in the US to be universally tested for HBV at least once in their lifetime and to test for total antibody to HBcAg, which may determine HBV in the window period and pick-up recent infection.

The new guidance, which is the first update since 2008, is aimed at providing more awareness around HBV and getting more people involved in the continuum of care. CDC is also expanding continual risk-based testing to include more groups, activities, exposures, and conditions, while noting the limitations to risk-based testing.

“Risk-based testing alone has not identified most persons living with chronic HBV infection and is inefficient for providers to implement,” the authors wrote.

Listed below are the new screening/testing HBV recommendations put forth:



• HBV screening at least once during a lifetime for adults aged ≥18 years (new recommendation)
• During screening, test for hepatitis B surface antigen (HBsAg), antibody to HBsAg, and total antibody to HBcAg (total anti-HBc) (new recommendation)

• HBV screening for all pregnant persons during each pregnancy, preferably in the first trimester, regardless of vaccination status or history of testing

• Pregnant persons with a history of appropriately timed triple panel screening and without subsequent risk for exposure to HBV (i.e., no new HBV exposures since triple panel screening) only need HBsAg screening

• Testing for all persons with a history of increased risk for HBV infection, regardless of age, if they might have been susceptible during the period of increased risk
• Periodic testing for susceptible persons, regardless of age, with ongoing risk for exposures, while risk for exposures persists

HBV awareness remains a significant health care challenge, despite existing therapies to treat it as well as prophylactic HBV vaccines to prevent it. It’s estimated that more than half of patients with HBV are unaware of their infection, mainly because virus presents asymptomatically in the majority of positive cases. Some people do eventually develop chronic hepatitis (elevation of AST/ALT), cirrhosis, or liver cancer.

Although there is no cure for HBV, treatment with any of the number of multiple antivirals available can make the virus a manageable, chronic condition.

On the vaccine side, there are prophylactic HBV vaccines, but uptake is limited. It has been reported that 70% of adults in the US were unvaccinated as of 2018.

In addition to the comprehensive screening and testing updates, the authors would like to see continued collaboration with laboratories to bundle the three HBV tests so they can be ordered together. And they also acknowledge the need to understand hepatitis D (HDV) more effectively to guide future recommendations for HDV screening among persons with HBV infection.

Conners EE, Panagiotakopoulos L, Hofmeister MG, et al. Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations — United States, 2023. MMWR Recomm Rep 2023;72(No. RR-1):1–25. DOI: 

The new guidance is the first update since 2008, replacing the previous risk-based recommendations. 

CDC Recommends Universal Screening for Hepatitis B Virus

A female patient in her mid 70s is admitted to a local hospital after presenting with shortness of breath and cognitive impairment that includes confusion. She has existing comorbidities that include edema and COPD after a long history of smoking.

A chest x-ray diagnoses the patient with pneumonia. And after a blood test, it’s confirmed the patient has bacterial pneumonia, but the precise organism is not determined. Because of the limited knowledge of the exact bacterium, the patient’s clinician treats her with broad spectrum antibiotics because of concerns related to multidrug resistant organisms such as Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus (MRSA).

The patient’s condition quickly worsens, and she falls into unconsciousness. She is placed on artificial breathing apparatus, and her family is called as the clinician treating her believes she may expire if she does not improve.

This becomes a wait-and-see situation with the family in limbo awaiting a potential worse-case scenario.

Fortunately, the antibiotics begin to take effect and the patient recovers, but not after the patient and her family have gone through a harrowing experience. Someday, possibly in the near future, patients may not need to go through this care scenario as clinicians may have the ability to identify the exact bacterium and prescribe the proper antibiotics—all in a shorter time.

In the aforementioned case, which continues to happen across the US health care system, clinicians are limited by the types of testing available and guidelines on how they treat. They treat broadly with antibiotics, and hope for the best possible outcomes.

The community hospital where the patient was treated had limited laboratory testing capabilities. The good news is diagnostic technologies are evolving, and lab panels have improved dramatically. These panels offer specificity and speed that can identify the bacteria quickly and reduce the time to optimal therapy (TTOT), thus leading to potentially more optimal treatment outcomes.

One example has been the development of multiplex polymerase chain reaction (PCR) panels that can be used to identify the rapid detection of pathogens in blood cultures, cerebrospinal fluid stool, and respiratory tract specimens.

Adoption of rapid PCR panels for positive blood cultures has been growing, and antimicrobial stewardship programs at many institutions perform audit and feedback based upon the results of such panels as a basis for interventions.

And the proliferation of these panels has helped to grow out the concept of diagnostic stewardship. This novel concept creates an emphasis to streamline the diagnosis process and get to TTOT more quickly. According to the CDC, “Diagnostic stewardship is defined as ordering the right tests for the right patient at the right time to inform and optimize patient care.”



Although these new rapid diagnostics enable specificity and speed, the challenges to widespread usage remain expense and availability. And even for those hospitals that can access such panels, it remains a priority to use them judiciously.

Lab Perspective: Who Will Run the Tests and Interpret Results?

Much like everything else in medicine, the laboratory is another field that is evolving. With these emerging rapid diagnostics comes the increased need to have more laboratory professionals run and interpret results of complex tests.And yet, labs have seen a series of challenges including more testing due to COVID-19—leading to burnout and staffing shortages.

“We've had these staffing issues for many years prior to the pandemic,” explained Rodney E. Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSc, university distinguished professor and chair of the Clinical Laboratory Science Program in the College of Health Professions at Texas State University where he also serves as the associate director of the Translational Health Research Center. “The pandemic has exacerbated these issues.”

Rohde remains in touch with many of his former students and says the pandemic has made for an interesting situation for lab professionals by increasing their value. It has created a hired gun atmosphere for experienced personnel where they are getting recruited to work with different institutions and leaving behind inexperienced lab technicians in their existing institutions.

“We're seeing some vacuums in trauma centers and major hospitals where now you don't have a mix of seasoned veterans and rookies,” Rohde explained. “I've talked with different people who are a little bit in panic mode, where they'll have one person, for example, working a night shift at a middle-of-the-road hospital that has some trauma issues in the middle of the night or during the day and the lab professional is left alone. And while we value every single medical lab scientist that we educate, we all know that on-the-job experiences, dealing with crises, and complex decision making should happen in the realm of seasoned veterans being around.”

Within the challenge remains the ability to determine and process so many tests, and this is where the rubber meets the road for diagnostic stewardship to go from novel concept to widespread reality.

Rohde points to education and the lab’s collaboration with clinicians as being potential strategies to aid in determining what tests are necessary. On the education side, he points to the new doctorate of clinical laboratory sciences (DCLS) degree, which is at three major universities. Rohde says lab professionals who have a few years experience may want to get their doctorate. 

With PhDs in hand, lab scientists can get more involved on the clinical side, especially as it pertains to testing.

“Those individuals will be rounding with physicians from a laboratory medicine standpoint, they'll be interacting with nurses, pharmacists, and the team in a way to help educate and inform proper and accurate test selection, ie stewardship, versus bartering every test, or ordering the same test over and over day after day when you may only need it once every five days,” Rohde stated.

Clinician Perspective: Solving the Testing Expense Issue

Although the advent of rapid diagnostics is a very needed addition, there remains the expense behind ordering these panels. And testing guidelines have not caught up to the new diagnostic technologies in determining who needs such tests.

As such, treatment guidelines are done on an institution by institution basis. One potential strategy to help in this area is using a combination of predictive tools and guidelines to help decide when rapid diagnostics are needed.

For example, clinicians have used the Drug Resistance in Pneumonia (DRIP) tool to aid in predicting cases of bacterial pneumonia that prove resistant to antibiotics. It can, however, still lead to some use of broad-spectrum antibiotics and over coverage.

Matthew Sims, MD, PhD, director of Infectious Disease Research, Corewell Health East, is a proponent of using the established DRIP in concert with rapid diagnostics. Sims and his team have done a lot of research using the rapid diagnostic the Unyvero Lower Respiratory Tract Panel (LRTP) and aided in obtaining its FDA approval.

In his research, he decided to study combining the two tools to see if they could improve diagnosis and tailor antibiotic treatment by creating an algorithm.

“Using an existing patient pool from a clinical trial of the LRTP, a DRIP score was determined for each patient. When data elements of the DRIP score were unavailable a DRIPmax and DRIPmin were calculated assuming all missing elements were positive or negative respectively,” Sims and his coinvestigator wrote about their methods. “The sensitivity and specificity of the DRIP score vs culture and LRTP were determined. An algorithm for antibiotic selection based on the results of the DRIP score combined with the LRTP was applied to each patient.”

This combination helped in finding patients who were susceptible to drug resistance.

“What we found is that if you use just the DRIP score as your initial cut and we’re going to run the [LRTP] panel on patients who have a score of four or more—which is the cutoff—you catch almost everyone who has a drug-resistant pathogen,” Sims stated.

Sims and his coinvestigator, medical student Richard Ramirez, developed their study’s results into a subsequent poster, “Combining DRIP Score and Rapid Diagnostics for Improved Antibiotic Stewardship,” which Sims presented at the infectious disease conference, ID Week 2022 in October.

Ultimately, the ability to bore down on diagnosis and timely, proper treatment is critical, especially in severe medical cases. And although the near term is undetermined in how to resolve these cost and guideline issues, innovation rules the day and modern medicine will find solutions to fix the problem.

“It's not something you can implement overnight, but we are seeing absolute payoff with our DCLS graduates that are aligning with healthcare systems and hospitals, not only in life and quality of patient care, but in actual dollars saved,” Rohde said. “If you don't order all of these tests, especially some of these expensive molecular assays, you can actually help the bottom line of a hospital and a medical lab. It's part of the ongoing conversation alongside other things to be more accurate, and quicker turnarounds—and all of those things that we need to do to improve patient care.” 

1. Miller M, et al. Early experience with the BioFire pneumonia panel. Contagion. 2020;05 (05): 16-17.

2. Banerjee 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

3. Current Stewardship Report. Centers for Disease Control and Prevention. Last reviewed October 6, 2022. Accessed December 20, 2022. https://www.cdc.gov/antibiotic-use/stewardship-report/current.html

This novel concept can benefit patients and clinicians alike by appropriately applying new technologies to identify bacteria more efficiently and decrease the time to optimal therapy.