Most people have heard of vancomycin AUC dosing, possibly even Bayesian dosing or Model-Informed Precision Dosing. What are the connections between these terms and what are their clinical relevance? In this blog, PrecisePK will guide you to understanding one of the most advanced methods to ensure drug safety, along with 5 overlooked facts about Bayesian method precision dosing. At the end of the reading, you will have a deeper appreciation of Bayesian dosing's financial benefits, its role and application in clinical workflow and healthcare technology, how it benefits education and research other than at the point of care, and lastly how it leads us into the age of personalized medicine.
Background: Understanding Bayesian Dosing’s Connection to AUC
Bayesian dosing, also known as precision dosing, is sometimes interchangeable with the term model-informed precision dosing. Bayesian dosing relies on Bayesian statistics, named after Thomas Bayes who first established the mathematical basis in 1763.
Bayesian dosing is highly adaptable and personalized as it calculates the updated probability of an event based on prior knowledge and new information. This approach incorporates covariates in population models such as CrCl in critically-ill patients. The patient's pharmacokinetic parameters are estimated before the first dose (Bayesian’s Priori) and updated after the administration of the first dose based on serum concentration measurements (Bayesian’s posterior).
The Bayesian approach is the preferred method to estimate the area under the curve (AUC), as it provides several advantages compared to traditional PK calculation. AUC calculation can also be accomplished on a formula-based approach, such as the trapezoidal model. However, manual AUC calculation is the most cumbersome and time-consuming, as it requires more computing efforts and pharmacokinetic sampling (at least two serum levels).
Bayesian Dosing Overlooked Fact #1: Vancomycin Dosing Guidelines | What You Didn’t Know
In 2020, a joint consensus guideline was published, stating that AUC-based dosing for vancomycin, recommending the AUC: MIC ratio 400-600 mg/L, and with the Bayesian approach, is the preferred method of choice to measure and monitor AUC¹. Vancomycin AUC dosing using Bayesian software is now widely accepted as the standard.
What does not get highlighted as often is that along with the guideline change, studies have demonstrated the financial benefits of Bayesian dosing. In 2014, Dr. Neely, MD, led a three-year study based on this hypothesis:
“many patients would likely achieve therapeutic medication levels when treated via AUC monitoring, despite having sub-therapeutic trough concentrations. Therefore, if clinicians were targeting trough concentrations with vancomycin, they were likely overdosing patients and increasing their risk of nephrotoxicity.”
The results of this study can be summarized in the following²:
- MIPD allowed for fewer samples per patient and reduced hospitalization duration by avoiding dosage adjustments and trough level checks.
- Dosing based on AUC levels was therapeutic for 70% of patients, compared to 19% based on serum trough levels.
- MIPD significantly reduced nephrotoxicity incidence while maintaining positive outcomes.
- Patients who did develop toxicity had an average length of stay of 20 days, resulting in approximately $145,000 of additional cost per patient compared to patients without toxicity.
Bayesian Dosing Overlooked Fact #2: MIPD can work seamlessly with existing practices to optimize clinical workflow.
- EHR Integration
With EHR integration, healthcare providers can quickly access patients' medical histories, laboratory data, medication information, and so on. This feature enhances communication, especially for hospitals that are short-staffed. EHR and Bayesian MIPD combined make personalized healthcare achievable, and more efficient, saving clinicians time and reducing the risk of errors.
- Antimicrobial Stewardship Program
Switching from trough to AUC-based calculations combined with a robust Therapeutic Drug Monitoring (TDM) application can facilitate a more agile oversight of safe antibiotic dosing. PrecisePK’s analytical reports let hospitals review their local populations' traits, therapeutic statuses, dosing strategies, and AKI incidence, also enabling easier annual audits. ASP directors can leverage the above features to optimize management, improve cost benefits, and decrease hospital expenditures³.
- Compliance Preparedness
MIPD software has the ability to incorporate any newly validated pharmacokinetics parameters from research quickly. With a streamlined workflow, adhering to clinical guidelines and making accurate decisions becomes coherent. Organizations of all sizes can be well-equipped to prepare and adjust to updated protocols. Investment in a precision dosing program shields administration and practitioners from any unexpected guideline changes and significantly reduces expenditure on time and labor.
- Real-time Alerts and Collaboration
MIPD software provides more than just dose recommendations to hospital pharmacists, it also serves as a collaborative tool and pushes real-time alerts for complex patient cases. Over a secured network, pharmacists and other healthcare professionals can access patient data and share medical inputs to work together on a case without switching interfaces. MIPD is designed to promote timely actions to be taken, avoid redundancies, and make high-quality patient care a consistent process.
Bayesian Dosing Overlooked Fact #3: Refine the state of the hospital's technology: detect any cybersecurity risks & evaluate the program’s adaptability
A recent study shows that from 2016 to 2021, ransomware attacks on healthcare delivery organizations doubled in frequency and increased in sophistication⁴. When selecting Bayesian software for vancomycin-AUC and many other drug models, it is noteworthy to not overlook these technical factors, for instance:
- Verify the algorithm’s maturity to produce unbiased results
- Inquire about training and onboarding assistance, post-integration resources, and support
- Test the interface’s ease of use, demand necessary customization
- Ensure data security level and adaptability
PrecisePK has achieved many highly recognized healthcare data and cybersecurity compliance, ensuring safety from both clinical and technological aspects for Bayesian AUC dosing software. PrecisePK is awarded the following: HIPAA Compliance Certification, SOC 2 Type II Certification, ISO 27001 Certification, and General Data Protection Regulation (GDPR).
When it comes to adaptability, communicate your organization’s needs in advance, especially for system-wide implementation. PrecisePK has been assisting clinical practices for decades, and we will likely have the answers you are looking for.
Here are some additional examples to help you ask the right questions–
Q: Is PrecisePK up-to-date with the latest clinical guidelines, and how often is PrecisePK updated?
A: PrecisePK helps you accelerate compliance with all the latest guidelines. We offer updates regularly to maintain the state-of-the-art of pharmacokinetics software. We update about once to twice a month.
Q: Does the PrecisePK license allow usage in more than one facility?
A: You can purchase the program for use on multiple sites and have the option to create a separate license per site using PrecisePK.
Bayesian Dosing Overlooked Fact #4: Pharmacists report satisfaction with Bayesian software use and they are not the only ones that benefit from using the software.
Clinicians from around the world, pharmacists included, have been finding the Bayesian dosing software not only extremely useful but also easy to become familiar with. In a survey conducted amongst PrecisePK’s all-time users, it was found that 98.2% of the users are confident with using PrecisePK’s Bayesian technologies, with more than half of them even expressing confidence in training others on how to use them. Then in a question asked to rate the ease of use of PrecisePK on a scale of 1-5, the average answer was 4.
The Bayesian method’s advantages are not capped at clinical uses. The thoroughly developed software converts sophisticated mathematical models into user-friendly instruments, adding value to many other applications. As a matter of fact, PrecisePK’s technology was many times utilized in independent clinical research to support pharmacology studies and helped establish unbiased conclusions, further benefiting the practice of care.
Bayesian Model-Informed Precision Dosing is also an invaluable educational tool, it can effectively train prospective health professionals on the use of technology in precision medicine. Hands-on experience in clinical drug dosing is also gained. Bayesian MIPD can benefit many educational settings, from pharmacy students to PGY residency programs to training modules or continuous education in teaching hospitals, its involvement can significantly promote a precise and personalized tomorrow of healthcare.
To learn more about how PrecisePK has been a world-class key player in Bayesian precision dosing and spearheading multi-sector collaborations, read our latest press release on partnerships with prestigious healthcare service providers, including Wolters Kluwer and Sanford Guide.
Bayesian Dosing Overlooked Fact #5: Bayesian precision dosing is a stepping stone to entering the era of personalized medicine.
In early 2023, PrecisePK predicted one of the hospital pharmacy trends to revolve around meeting requirements in care, compliance, and cost with clinical technology. A supporting element to this prediction is the rise of the importance of patient-centered or care-centric care, from early-phase drug development to clinical trials to market approval.
The new tune of drug development, with precision, is conveyed mostly through the tightening of compliance and more stringent guidelines for clinical actions. Healthcare practitioners can count on the Bayesian dosing method to take each patient’s characteristics into consideration especially when conducting infusion treatments using narrow therapeutic index drugs. Meanwhile, the life science sector will see more motions attuned to individual characteristics during development as FDA recently rolled out a Diversity Action Plan for clinical trials.
As more and more research studies unveil the inaccuracy and inefficiency of the status quo— adjusting drug dosages based on mere height and weight or preassumed gender-based ratio, one-size-does-not-fit-all will be here to stay for decades to come. Other undertakings led by policymakers concerning this aspect include Project Optimus, an initiative to reform the dose optimization and dose selection paradigm in oncology drug development, and the continuation of the MIDD Pilot Program, an approach that uses a variety of quantitative methods to help balance the risks and benefits of drug products in development.
Currently, vancomycin is one of the top sought drugs for the implementation of Bayesian AUC dosing, yet many other therapeutic areas would benefit from this practice. PrecisePK’s drug models cover infectious diseases such as beta-lactam antibiotics and various other areas like oncology, transplant, pulmonology, neurology, and cardiology. Special populations and extra drug factors within these areas are also a big part of what the MIPD targets, including neonatal, pediatric, ICU, obesity, burn patients, amputation, generic variation, hemodialysis, and much more.
With the persistent global labor challenges, nurses and pharmacists face added workloads with enlarged responsibilities. Providing them with effective and reliable clinical decision support tools would be a momentous leap into evidence-based practices without compromising the highest standard of care. The Bayesian method is a way to reduce clinical workload (by replacing hand calculations for dosage, providing flexibility in blood draws, etc.) and maximize patient safety, all while ensuring therapeutic efficacy and the optimal practice of antibiotic stewardship.
To transport into the future where treatment is effective for all, especially for those receiving cancer treatment, Precise PK uses the Bayesian approach to advance the implementation of TDM in settings of all complexity and makes precise dosing practical in a clinical environment.