This patent application has not been assigned to a company or institution.
The following quote was obtained by the news editors from the background information supplied by the inventors: "The present invention relates generally to drug prescription practices for healthcare providers. More particularly, this invention relates to a system and method for diagnostic monitoring of drug and biomarker levels, relating these measured levels to other patient-specific characteristics, and utilizing this real-time and measurement-based drug level data for optimizing medication choice and dosages for patients taking more than one medication.
"Therapeutic Drug Monitoring (TDM) is a term that describes the measurement of drug exposure in serum or plasma to tailor dosing in an individual patient. Tailored dosing in individuals is necessary because a multitude of parameters, such as body weight, overall health, patient behavior, and genotype underlie variable drug exposure in patients administered the same dose of a given medication. Different exposures result in different outcomes. For some drugs, such as the blood thinner Warfarin.TM., TDM is routine, with the physician starting, on a patient by patient basis, with very low doses and slowly titrating to efficacious blood levels to avoid potentially fatal bleeding.
"TDM is not routinely practiced with most medications, not because exposure is any less dependent on individual patient parameters, but because it is not deemed necessary when the margin between efficacy and toxicity is wide. Therefore, TDM is typically deployed to avoid toxicity rather than to maximize the effectiveness of individual drugs.
"Drug exposure is not only dependent upon the physical makeup of individual patients, but also upon interactions with other drugs that are concomitantly administered. Drug-drug interactions (DDI's) have a substantial impact upon patient outcomes, even with very commonly administered medications. Simvastatin.TM., for example, is one of the world's most prescribed medications. Co-administration of drugs that inhibit metabolic enzymes and transporters, such as cyclosporine, can drive Simvastatin.TM. exposure in individual patients upward more than ten-fold, increasing incidence of rhabdomyolysis, a serious and sometimes fatal toxicity of the muscle. This type of interaction is common, and nearly all new medications brought to market carry with them some interaction potential as either a perpetrator or victim of drug drug interactions despite the best efforts of the pharmaceutical industry ('pharma').
"One key point which is worth considering is that the therapeutic range of Simvastatin.TM. and virtually all other drugs are known or at least predetermined. Exposure and identification of medications outside of their range may be easily monitored by measuring drug levels in blood, but measuring drug exposure, especially the exposure of multiple drugs in unison, is not standard practice today. Assays that combine the measurement of drugs and biomarkers in multiplex format to decrease diagnostic costs while streamlining prescribing practices are further not previously implemented in the art.
"The influence of genetics, patient characteristics and behaviors, environment, and drug-drug interactions on patient outcomes have all been studied on an individual basis, but currently have little impact on physician prescribing habits. Currently, a physician cannot account for the inherent complexity these parameters impart when prescribing a new medication to a patient, especially given that patients over 65 years of age are often taking 8 or more medications simultaneously. In fact, prospectively building models that predict drug exposure in an individual patient's overall treatment regimen to help guide physicians in drug selecting and dosing would require a comprehensive data set that simply does not exist today. Drug exposure in the light of complexity must be quantified if we are to understand drivers of patient variability.
"Therefore, what is needed is a system and/or method for measuring the exposure of all concomitant medications in individual patients and a means to apply this information to inform physician prescribing practices. Such systems and methods may desirably serve one or more purposes including but not limited to: providing a real-world diagnostic monitoring; enabling better prescribing practices resulting in reduced risk for patients; yielding more effective treatment outcomes by increasing compliance, decreasing hospitilizations and optimizing medication choice; streamlining costs by integrating biomarker and therapeutic drug monitoring assays; producing valuable data necessary for prospective modeling of patient characteristics and reporting measures for better drug development in the future; and yielding critical insights on the benefit-risk and the real world effectiveness of pharmaceutical products for regulators, payers, HTA agencies, pharma and ultimately, patients.
"It would be desirable that such systems and methods produce results easily for presentation to the physician in a simple format such that prescribing practices can be optimized for each patient in, e.g., a fifteen minute consultation.
"Therefore, it would further be desirable to restrict the amount and scope of information provided, and to present this information in a graphical format with clear recommendations."
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors' summary information for this patent application: "In accordance with various embodiments and associated aspects of the present invention, systems and methods as described herein are implemented for understanding patient variability in drug response resulting in the refinement of current prescribing practices and leveraging recent advances in mass spectrometry and informatics. A universal drug monitoring diagnostic tool is provided and executed for producing a simplified, comprehensive report that allows physicians to make informed prescription decisions in real time with individual patients.
"Underlying this report are complexities that drive patient variability that are taken into account and presented to the physician in the form of drug selection and dosing recommendations. These constantly evolving/improving data-driven recommendations informed prescribing more so than current alert systems, which are overwhelmingly overridden in current practice today.
"In one aspect of a system and method of the present disclosure, this diagnostic tool and associated implementation methods (which may in certain embodiments described further herein be referred to herein as 'Comprehensive Informed Prescribing' or 'CIP') is a solution that leverages exposure of multiple medications and biomarkers simultaneously, allowing data-driven prescribing decisions based on individual drug levels in the context of for example other drugs, patient characteristics and reporting measures.
"In another aspect, systems and methods as disclosed herein factor underlying patient, environmental and drug-driven variability and puts them in the hands of the physician in an easy to administer format.
"In another aspect, systems and methods as disclosed herein may measure multiple (e.g., >100) chemical entities in a multiplex format for the purpose of providing quantitative data for informed dosing. Chemical entities include not just single victim drugs that fit the criteria for single drug monitoring, but perpetrator drugs that interact with victim drugs and drive DDIs. Further, endogenous biomarkers, non-prescription drugs, specified food additives, and natural products may be included in measurement. It is anticipated that demand created using this approach will result in improved multiplex assay formats being developed over time for the purpose of comprehensive informed prescribing, and the use of these multiplex assays for informed prescribing is also considered within the scope of various embodiments of a system and method as disclosed herein.
"In another aspect, systems and methods according to the present disclosure may implement algorithms associating multiplex drug measurement data with patient meta-data and outcome data, models derived from these associations, and any novel recommendations that impact drug administration resulting from initial multiplex drug measurement. Associations may be made with non-traditional data, such as patient characteristics and behaviors, genetic makeup, disease state, and compliance (measured).
"In another aspect, systems and methods according to the present disclosure may generate an informed prescribing report that allows physicians to make point-of-care decisions based on graphical output depicting each chemical entity detected, the measured value of that entity, the value of that entity relative to targeted therapeutic range, and recommendations based on the output from a contextual effectiveness database.
"In another aspect, systems and methods according to the present disclosure may implement a comprehensive exposure/outcome database, models derived therein, and novel drug-drug and drug-chemical interactions detected using these models. The application of these models may extend back to drug development in the form of alerts for avoidable DDIs and previously unidentified avenues of unmet patient need.
"In another aspect, systems and methods according to the present disclosure may implement multiplex drug measurement in streamlining assay cost, physician decision making, maintaining of patient health, improving compliance and overall efficacy, and preventing adverse events.
"In another aspect, systems and methods according to the present disclosure measure all marketed drugs and produce an output of only relevant information that identifies information such as for example: which drugs the patient is taking (compliance); the level of each drug relative to the desired therapeutic range; and treatment options for each drug (including drug switching) when the level is either too high, too low, or subject to interactions leveraging context of the CIP database.
"In another aspect, systems and methods according to the present disclosure generate and provide an output to a physician or other healthcare provider, having sufficient data and clear recommendations to treat the patient with autonomy. In various embodiments, additional parameters may include for example co-measurement of key select biomarkers, non-prescription medications and other influencing factors.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
"FIG. 1 is a block diagram representing an exemplary embodiment of a system of the present disclosure.
"FIG. 2 is a graphical representation of exemplary parameters as may be influencing individual drug levels with respect to a drug level monitoring process of the present disclosure.
"FIG. 3 is a flowchart representing an exemplary process of the present disclosure.
"FIG. 4 is a modified screen shot representing an exemplary user interface as a drug level report according to the present disclosure.
"FIG. 5 is a modified screen shot representing an interactive version of the user interface of FIG. 4."
URL and more information on this patent application, see: Ryan, Douglas J.; Blackshear,
Keywords for this news article include: Patents, Therapy.
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