OUTLINE
Professional Standards of Practice
Elements for Prospective Drug Utilization Review
What to Do When a Problem is Identified
I. DEFINITIONS
A. “Drug Utilization Review” (DUR) is a process used to assess the appropriateness of drug therapy by engaging in the evaluation of data on drug use in a given health care environment against predetermined criteria and standards (1).
1. This definition was published as part of a report called Principles of a Sound Drug Formulary System. The report was prepared and endorsed by a coalition of national organizations, including the Academy of Managed Care Pharmacy (AMCP), the American Medical Association, the American Society of Health-System Pharmacists (ASHP), and the United States Pharmacopeia (USP), with a primary interest in promoting rational, clinically appropriate, safe, and cost-effect drug therapy (1).
2. There are three distinct types of DUR: prospective, concurrent, and retrospective DUR.
a. Prospective DUR is the review that a pharmacist conducts prior to dispensing a new or refill medication. The prescription or medication order is compared with predetermined criteria to prevent or correct a potential drug-related problem before it reaches the patient. Criteria may be determined by state Medicaid programs or private-sector prescription programs (e.g., pharmacy benefit managers and managed care organizations) and is available online through the pharmacy’s computer system to immediately “alert” the pharmacist to a “violation” of the criterion. However, each pharmacist, using his or her own pharmaceutical care knowledge and professional judgment, should be able to perform a basic DUR without the assistance of computer software because a potential drug therapy problem could exist but not trigger a prospective DUR program. If a potential problem is identified, the pharmacist contacts the prescriber with recommendations for change. This type of DUR is ideal, as it identifies problems before they occur and allows for individual patient-centered interventions by the pharmacist (2).
b. Concurrent DUR is a review that is performed during the course of treatment and involves the ongoing monitoring of drug therapy to ensure positive patient outcomes (3). This type of DUR is commonly performed in institutional settings (e.g., hospitals) and allows the pharmacist to alert prescribers to potential problems and adjust medication therapy if necessary on the basis of ongoing diagnostic or laboratory tests.
c. Retrospective DUR is a review of a large number of prescription orders that have already been dispensed. Data are obtained using a pharmacy’s or third-party payer’s (e.g., state Medicaid or private-sector prescription programs) billing claims that are screened for potential patterns or problems, such as fraud, abuse, overuse, or inappropriate or medically unnecessary care among physicians, pharmacists, and patients. Similar to the other types of DUR, each retrospective DUR has established criteria in which to screen the data for “violations.” Once a “violation” is identified, an “alert” is generated, and those practitioners involved are educated by mail or via telephone. A typical “alert” letter sent to practitioners contains the name of the patient, an introduction to the DUR program, information describing the criterion that has been “violated,” literature references supporting the validity of the criterion, and a listing of the prescriptions and medical diagnoses that are exceptions to that particular DUR. This educational process is intended to minimize inappropriate prescribing in the future (4). Though the easiest and least costly to perform, retrospective DUR does not provide the pharmacist with an opportunity to modify drug therapy before it is dispensed (3). Many health care systems have shifted from the traditional retrospective DUR, with its focus on drug-specific problems, to include disease management concepts, such as evidenced-based treatment guidelines and algorithms, to ensure patient-centered, cost-effective, and clinically efficacious care (3).
B. “Drug Use Evaluation” or “Drug Use Review” is a process that involves the formal development, monitoring, and adjustment of objective, measurable criteria that describe the appropriate use of a drug (5). The underlying concepts of drug use evaluation (DUE) are now contained as part of the more current and broader concept of medication-use evaluation (6).
C. “Medication-Use Evaluation” is a performance improvement method that focuses on evaluating and improving medication use processes with the goal of optimal patient outcomes (6).
1. A medication-use evaluation (MUE) focuses on the outcome of a patient’s medication therapy according to predetermined criteria. The goal of the evaluation is to optimize medication management and improve the patient’s quality of life throughout all phases of the medication-use process (6). The medication-use process includes the responsibilities of prescribing, preparation and dispensing, administration, and monitoring of medications. The medication-use evaluation is concerned with the interrelatedness of these functions and the continuum of care.
2. A MUE can be initiated for a variety of reasons and is not restricted to the prescribing and dispensing functions of a pharmacist. It can evaluate a single medication, an entire therapeutic class of medications, various disease states or conditions, and actual or potential medication-use process problems. Reasons prompting a MUE include the following:
a. Problem-prone drugs
b. High-volume and high-cost drugs
c. High-risk medications
d. High-risk patient populations
e. New drug entities
f. New therapeutic plans
3. A MUE can be conducted in any health care setting provided the process is interdisciplinary, collaborative, and prospective and has access to comprehensive patient information.
4. The MUE is compatible with the performance improvement model. The performance improvement steps of “Plan, Do, Check, and Act” are paramount to the MUE process. The evaluation process not only provides a guide to optimize therapy management, prevent medication-related problems, control costs, and maximize patient safety, but it also provides insight into the appropriateness of the criteria used and optimal functioning of the medication-use process. Therefore, the MUE has become an essential component of performance improvement initiatives within many health care systems.
D. “Criteria” are predetermined parameters of drug prescribing and use established by a DUR program for comparison to actual practice. Development of criteria is the collaborative responsibility of practitioners (e.g., physicians, pharmacists, and nurses) and administrators and is based on standards of practice and evidence-based guidelines published in the primary literature.
II. HISTORY
A. Drug Utilization Review (DUR)
1. DUR has been mandated by our federal and state governments for several decades and is required by organizations that seek government funding for medical services provided to Medicare and Medicaid patients.
2. The funding of health care began in the 1930s with the creation of the Social Security Act. Medicare and Medicaid came into existence in the 1960s to address the financial needs of patients in nursing facilities. In 1967, Congress authorized the first set of standards for nursing facilities. Since that time, several regulations have been adopted and amended. Though long-term care (LTC) facilities and hospitals have been under these regulations for the longest period of time, outpatient providers of care, including managed care organizations, home health care agencies, and mail order pharmacies, are also included under these regulations. Outpatient prescribing practices were brought into the review process in the 1990s with the passage of the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90).
3. OBRA ’90 (42USC1396r-8) mandated the formation of DUR boards by each state for providing outpatient prescription services to state Medicaid patients. The intent of OBRA ’90 was to increase patient education and promote appropriate medication use through prescribing practices, thereby controlling health care costs funded by the government.
a. Three excerpts from the current version of OBRA ’90 that are relevant to DUR requirements for pharmacists are given here (7).
(1)… a State shall provide… for a drug use review program… for covered outpatient drugs in order to assure that prescriptions (i) are appropriate, (ii) are medically necessary, and (iii) are not likely to result in adverse medical results. The program shall be designed to educate physicians and pharmacists to identify and reduce the frequency of patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care, among physicians, pharmacists, and patients, or associated with specific drugs or groups of drugs, as well as potential and actual severe adverse reactions to drugs including education on therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse.
(2) The State plan shall provide for a review of drug therapy before each prescription is filled or delivered to an individual receiving benefits under this subchapter, typically at the point-of-sale or point of distribution. The review shall include screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindication, drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs), incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse.
(3) As part of the State’s prospective DUR program… applicable State law shall establish standards for counseling of individuals receiving benefits under this subchapter by pharmacists…
b. As DUR is required by all states and in all health care settings, you should become knowledgeable about the applicable statutes requiring DUR activities for the state in which you are practicing.
4. The USP has also developed and published similar standards to be incorporated by the state DUR boards. Standards are established and enforced by the Health Care Finance Administration (HCFA), and the focus of these standards is to prevent the following:
a. Over/under-utilization of drugs
b. Duplication of therapy
c. Drug-drug, drug-food, drug-disease, and drug allergy interactions
d. Incorrect dosage or duration
e. Clinical abuse or misuse
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