The Needed Innovation for Safe and Effective Drug Therapy
The University of Minnesota has chosen Medication Management Systems, Inc. to license the Assurance Pharmaceutical Care System. Please contact www.medsmanagement.com for more information.
Description
Assurance Pharmaceutical Care is a computer-based documentation system designed to support the practice of pharmaceutical care. This program is used by pharmaceutical care practitioners to manage all of a patient's medications and to document outcomes from drug therapies, cost savings, and clinical improvement in patient care. It supports all reimbursement methods and practitioners providing medication therapy management (MTM) services to patients on a continuous basis, over repeated patient encounters, at multiple practice sites, by multiple practitioners, and it is fully developed to support an entire network of practitioners. Medicaid and Medicare Part-D MTM billing forms are automatically generated for reimbursement. The Assurance Pharmaceutical Care system is a breakthrough program based on over 15 years of research by the faculty from the Peters Institute of Pharmaceutical Care at the University of Minnesota, including Robert Cipolle, Linda Strand, Peter Morley, and Michael Frakes.
The program operates by generating and storing a comprehensive pharmaceutical care patient record for each patient. This includes complete patient demographic information and an individualized care plan to manage the drug therapy of each and every medical condition. All best practices care plans for medical conditions are automatically coded using the most widely accepted system in use today (ICD-9-CM classification). The medical conditions are associated with the specific drug therapies, including product, dose, route, schedule, and duration. This medication management system allows the practitioner to document cost savings resulting from the identification, resolution, and prevention of drug therapy problems at the point of service. A unique classification system was developed for drug therapy problems and their most common causes.
Table 1: Drug Therapy Problem Codes
| Type |
Cause |
| |
None known at this time |
| Indication |
No valid medical indication |
| Unnecessary drug therapy |
Duplicate therapy |
| |
Non-drug therapy appropriate |
| |
Treat avoidable adverse reaction |
| |
Drug abuse, alcohol use, or smoking |
| Indication |
Untreated condition |
| Need for additional drug therapy |
Preventive therapy |
| |
Synergistic therapy |
| Effectiveness |
More effective drug available |
| Ineffective drug |
Condition refractory to drug |
| |
Dosage form inappropriate |
| |
Drug not indicated for condition |
| Effectiveness |
Dose too low |
| Dosage too low |
Dosage interval too infrequent |
| |
Drug interaction |
| |
Duration inappropriate |
| Safety |
Undesirable reaction |
| Adverse drug reaction |
Unsafe drug for patient |
| |
Drug interaction |
| |
Dose increase/decrease too fast |
| |
Allergic reaction |
| |
Drug product contraindicated |
| Safety |
Dose is too high |
| Dosage too high |
Frequency inappropriate |
| |
Duration inappropriate |
| |
Drug interaction |
| |
Dose administered too rapidly |
| Compliance |
Patient does not understand |
| Noncompliance |
Patient prefers not to take |
| |
Patient forgets |
| |
Cannot afford drug product |
| |
Cannot swallow/administer |
| |
Drug product not available |
This system tracks the actions that were taken to resolve drug therapy problems, as well as the economic impact in terms of health care costs savings or costs. Such as using this relational database, allows pharmaceutical care practitioners to record health care savings that occurred due to the identification and resolution of drug therapy problems. Health care savings include the avoidance of physician clinic visits, emergency department visits, or hospitalizations due to ineffective drug therapies, toxic or adverse reactions to medications, or other drug therapy problems. Drug savings and costs that result from pharmaceutical care services can also be recorded and analyzed.
The Assurance system also records actual patient outcomes using a unique classifying description of outcome status. These classifications describe both the status of the medical condition being managed with drug therapy and whether changes in drug therapy were required. It can be used longitudinally to follow progress in both acute and chronic disorders. The Assurance system records coded patient outcomes and organizes results by disease state with the associated improvements in each patient's drug therapy.
Follow-up Evaluation
Each follow-up evaluation contains a clinical judgment as to how effective the care plan and the associated drug therapies have been in achieving the goals of therapy for each of your patient's medical conditions. From the information gathered at the follow-up evaluation, the practitioner evaluates the actual outcomes and documents the progress (or lack of progress) in achieving the goals of therapy. The status of each medical condition being managed by medications is evaluated at each follow-up encounter. These are described as resolved, improved, partial improvement, stable, not improved, worsened, failure or expired. The definitions of the outcome status terms contain a clinical decision and an action on the part of the practitioner.
Summary of Outcomes Status Terminology
Pharmacotherapy Outcome Status |
Definition (progress toward goal and action required)
|
| Resolved |
Goals of therapy have been achieved. Drug therapy has been completed or can now be discontinued. Usually associated with therapy for an acute disorder. |
| Stable |
Goals of therapy have been achieved. The same drug therapy will be continued. Usually associated with therapy for chronic disorders. |
| Improved |
Adequate progress is being made toward achieving the goals of therapy at this point in time. The same drug therapy will be continued. |
| Partially Improved |
Some measurable progress is being made toward achieving the desired goals of therapy, but some adjustments in drug therapy are required. Usually dosage changes or the addition of additive or synergistic therapies is required. |
| Unimproved |
No measurable progress in achieving goals of therapy can be demonstrated at this time. It is judged that more time is needed to produce adequate response. No changes will be made. The same drug therapy will be continued at this time. |
| Worsened |
There has been a decline in health status while receiving the current drug regimen. Some adjustments in drug product selection and/or drug dosage are required. |
| Failure |
The goals of therapy have not been achieved despite adequate doses and adequate duration of therapy. Discontinuation of the present medication and initiation of new drug therapy is required. |
| Expired |
Patient died. |
A Written Patient Record
The Assurance system allows patients to take charge of their own health care decisions. It provides the patient with a personal pharmaceutical care plan report including all medications, including the indication for each product, the prescriber, clear directions, goals of therapy, allergy and medical alert warnings, associated health care advice, and a schedule for follow-up evaluations. Copies (paper or electronic) of these patient-specific electronic therapeutic records are available for the patient's own use as well as for inclusion in the patient's general medical records in the physician's or clinic office. Assurance also creates a medication therapy management (MTM) report to communicate your recommendation to the physician.
A computer support system is integral to the provision of care, documentation of care, and analysis of results. The support system for the service is an electronic charting system specifically designed to help provide and document pharmaceutical care. It collects patient demographics, drug interaction checking, disease specific care planning, medication documentation, drug therapy problem identification, follow-up evaluations, physician and patient reporting, billing, workload tracking, clinical outcome tracking, and data consolidation.
Examples of patient reports:
(Note: You will need the Adobe Acrobat Reader to access these documents. This free software can be downloaded via this link.)
Patient Confidentiality
The Health Insurance Portability and Accountability Act (HIPPA), enacted in 1996, mandates that patient confidentiality be strictly maintained. We have addressed the recommendations with respect to the privacy of certain health information described in Section 264. Pharmaceutical care practice, as well as the clinical documentation system that supports the practice, and the proprietary central database functions described in section III of this proposal, all hold patient confidentiality as a high priority. Patient names are maintained only at the practice site where the patient receives services, and records sent to the host databank are stripped of patient identifiers. No information is collected without the expressed consent of the patient or the patient's agent. To this end, the system contains a patient consent form. As the program has no predetermined, required fields, the practitioner can keep data gathering, especially of "patient, personal, protected health information (PHI)" to the minimum necessary to serve the patient's drug-related needs.
Anytime we consolidate data, patient identifiers are removed from the data fields so there is no reasonable basis to believe it could be used to identify the individual patient. Any patient who requests that his/her data do not become part of the centralized data pool will have that request honored. We can select out any record so that it is not consolidated with others.
All access to clinical records as well as consolidated data are password protected and are maintained in encrypted form at all times. We have the capacity to maintain records for the required six-year period or longer.
To date, over $10 million has been invested in the development, testing, and evaluation of this service and the accompanying software technology. Almost 25,000 patients have received pharmaceutical care in practices developed by University of Minnesota College of Pharmacy faculty. Since its initial development, the practice and software technology have been used to record over 75,000 patient encounters.
For more information about this software program, please send inquiries to www.medsmanagement.com.