Measuring Clinical Effectiveness
BACKGROUND AND NEED
Contemporary issues facing institutional managers, as well as P&T committee members, focus heavily on balancing patient care costs and outcomes. That balance should assist organizations in achieving their value propositions in providing optimal patient care—in this case, through the appropriate use of pharmaceutical agents. Achieving a balance requires informed decision-making along with access to the appropriate data that will assist in assessing both cost and outcomes.
Clinical effectiveness can be thought of as doing the right thing for the right patient, at the right time, in the right setting, using the right resources to obtain the right outcome at the right cost. This is a useful concept for tying together all of the elements embodied in health care “value,” particularly when clinicians and administrators must work together on complex issues of clinical care and economics. The development of hospital formularies and the management of pharmacy department expenses are excellent examples in which important goals are frequently impeded by the resistance of medical staff members to cost-effectiveness reports. Unfortunately, hospitals continue to focus on drug-acquisition costs, probably because most hospitals do not have robust, credible data on the overall costs of treating patients to do otherwise. This puts enormous pressure on pharmacy managers.
The long-standing method of evaluating the cost of a medication, or a class of high-cost medications, in a hospital is the traditional patient record, or the drug utilization review (DUR).
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The DUR is a formal, stepwise approach that evaluates the clinical appropriateness and patterns of use, adverse drug events (ADEs), and acquisition costs. When applied well, DURs can offer significant insights into improving medication use while reducing errors and the associated medical-legal risks. The limitations of DURs relate to the “silo” in which they are performed; DURs generally concern only acquisition costs (and occasionally administration costs), and they lack a multi-disciplinary view of the entire patient-care process.
Physicians sometimes find DUR data to be less than compelling because they believe that newer, more expensive drugs often provide a combination of fewer complications, improved patient satisfaction, and better overall patient outcomes. This belief often places physicians in opposition to hospital administrators (and the administrators of managed care plans), who respond that there is no proof that the newer drugs provide better outcomes at a price that justifies their use.
The heart of this crucial disagreement is the absence of credible data about the overall cost of treating patients with newer drugs compared with that of using older, less expensive medications. Administrators also have a stake in this dilemma: it would be inappropriate to advocate the use of a drug that is less costly to acquire if the resultant delivery costs, length of hospital stay, complications, and effectiveness all contributed to a higher total cost.
In response to these limitations, a new integrated approach called the Clinical Effectiveness Initiative (CEI) was developed. Like some other assessments, it uses standard administrative databases, available at every hospital in the U.S., to evaluate the overall cost of treating patients. In addition to detailed pharmacy expenses, the CEI includes laboratory, medical/surgical supplies, intensive care, and all other department expenditures for patient care. Unlike DURs and other assessments, the CEI allows for robust and detailed comparisons of overall hospital costs involved in treating patients with one drug versus another.
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The first CEI focused on a comparison of unfractionated heparin (UFH) with low-molecular-weight heparins (LMWHs). Considering the enormous cost of venous and arterial thromboembolic disorders and the rise of LMWHs to one of the top five (often the top one or two) line items in hospital pharmacy budgets, this comparison is very timely and relevant to institutions. In this article, we describe the integrated method used in the CEI, an approach that can be used for any therapeutic category of drugs.
DATA
For a CEI to be successful, data must be available for all patients in a hospital; selecting only a subset of patients might omit much available useful information. For example, selecting only patients who have received anticoagulants would omit information about patients who should have received prophylactic anticoagulation but did not.
Table 1 Patient Data Items for Clinical Effectiveness Initiative
|
From Uniform Billing System |
| • Patient identifier (e.g., a masked or encrypted number unique |
| to each patient to allow the identification of readmissions and, |
| if needed, to allow the hospital to retrieve records) |
| • Admission identifier (a masked or encrypted number unique |
| to each hospital stay) |
| • Admission date |
| • Discharge date |
| • Patient date of birth (or calculated age and, for neonates, age |
| in days) |
| • Patient sex |
| • Birth weight (for neonates only) |
| • Discharge status |
| • Principal and 14 secondary diagnoses |
| • Principal and 14 secondary procedures |
| • Attending physician’s identifier and specialty |
| • Total charges |
| • Charges by Uniform Bill 92 Revenue Code |
|
From Pharmacy or Billing System |
| • Admission identifier for linking to the Uniform Billing |
| Data for the same admission |
| • Drug identifier |
| • Quantity |
| • Charges |
| • Date of service |
Patient data for CEIs were obtained from standard detailed billing data sets, available at most U.S. hospitals. Table 1 lists the data items provided by participating hospitals. For those patients who were discharged over a two-year period or longer, all diagnostic and procedural information (coded using the International Classification of Diseases, 9th revision, with Clinical Modifications) were obtained along with demographic information. In addition, charges by the Uniform Billing Revenue Code were obtained along with detailed charge data for the pharmacy department. This latter data set included all drugs charged to a patient for each day of a hospital stay: a drug identifier, the quantity dispensed, the charge, and the date of service.
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In addition to patient data, the CEI used data from the Medicare cost report (CMS Form 2552), filed annually by all hospitals in the U.S. These reports included data for expenses, charges, and statistics that were used to calculate the costs of care at the patient level (see “Patient Cost Calculation” later).
