Background

The Omnibus Budget Reconciliation Act of 1990[1] required each state to establish a program that retrospectively reviews the prescribing and dispensing practices of outpatient prescription medications "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 is designed as an educational tool to help physicians and pharmacists (and presumably other Medicaid prescribers)

"...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."

OBRA 90 Mandated Drug Use Review (DUR)

What is it and how is it performed?

The College of Pharmacy at Idaho State University has served as the State's DUR contractor since January 1993. During this time, significant effort has been expended towards the design, implementation, and management of a comprehensive "state of the art" DUR program. Responsibilities and contributions provided by the College's DUR team, hereafter referred to as the DUR staff, include the following components:

Establishment of a Clinical Database from Medicaid "BillingClaims"

Although the Idaho Medicaid program is extensively computerized, the system is primarily devoted to claims processing and payment activities. Thus, development of a relational database utilizing paid prescription drug claims and physician services claims was initially undertaken. Design and implementation of an operational DUR database was accomplished within the first six months of the DUR program. This software, specifically tailored to the Idaho DUR program, allows drug and medical history profiles to be constructed for individual patients, and facilitates aggregation of patient specific data into physician prescribing and pharmacist dispensing profiles. Review and evaluation of these profiles, by the DUR Board and staff, is the basis for determining patterns of cost-ineffective, medically unnecessary, or potentially high risk drug use (see retrospective DUR discussion below).

Development of Drug Use Criteria

Over the past three years, the DUR staff have created explicit drug use criteria covering 14 drug classes and approximately 200 of the most commonly prescribed drug products. These criteria represent standards or guidelines for appropriate drug use as well as identifiable circumstances in which specific drug therapy entails a high risk for adverse effects. Employing the expertise of individual faculty members within the College, criteria were formulated using standard drug compendia and an extensive review of the clinical literature. All criteria were reviewed, modified as necessary, and approved by the DUR Board.

To facilitate more efficient program operation, the DUR staff employed a unique ranking scale to assist providers in identifying high cost or high risk drug use. Additionally, the scale is intended to help eliminate needless communication with providers about minor drug-related problems. Approximately 100 drug specific criteria have been designated as potentially high cost or high risk drug use situations in which communication with physicians and pharmacists, alerting them of the potential problem, is deemed necessary.

Prospective versus Retrospective DUR Activities

As the state's contractor, the DUR staff have been responsible for developing, successfully implementing, and maintaining the OBRA 90 mandated retrospective DUR component. Retrospective DUR, as used here, refers to a computerized review process which takes place after drug use has occurred. Sophisticated computer software described above is used to apply drug use criteria to the DUR database of paid prescription and medical claims. The initial computerized review is subsequently rechecked manually by DUR staff to determine physician and pharmacist compliance with drug use standards. Additionally, since many patients see several physicians and/or pharmacies, the DUR database is frequently used to identify situations of medication overuse or abuse by recipients or high risk drug therapy due to multiple providers. In the latter circumstance, the DUR review program frequently provides extremely valuable information to physicians and pharmacists who may be unaware of each others contribution to the recipient's medical care.

All currently approved drug criteria are intended to be used prospectively as well i.e., incorporated into daily professional practice by physicians at the time of prescribing and pharmacists at the time of dispensing. Although no formalized program is currently operating, Health and Welfare is soliciting bids for an on-line prospective DUR component as part of its claims processing package. In addition to facilitating claims processing, electronic submission of prescription claims would permit concurrent review of new prescriptions against DUR criteria to insure that inappropriate drug therapy is identified and corrected prior to drug dispensing. Warnings of DUR criteria violations could be electronically returned to the dispensing pharmacy notifying them of potential problems before the prescription is dispensed.

While prospective DUR review is clearly the ideal, it must be emphasized that prospective review does not abrogate the need for continued retrospective review. Since few circumstances exist in which drug use is absolutely prohibited, in any individual patient, mitigating circumstances may compel the use of potentially dangerous drug therapy due to a lack of effective alternatives or the potential for benefit to outweigh potential risks. Hence, during prospective DUR there are occasions when electronic warnings may be appropriately overridden. Providers who consistently ignore DUR warnings or demonstrate a consistent pattern of inappropriate prescribing or dispensing, however, will be detected by retrospective review. Thus, prospective review seeks to identify individual patient cases at increased risk for adverse effects; retrospective review attempts to detect individual providers with dispensing or prescribing problems through review of multiple patient cases (i.e., pattern analysis). For successful and comprehensive DUR, both types are necessary since they fulfill different objectives.

The DUR Board

The DUR Board is the decision-making body responsible for implementing and operationalizing the DUR program. Comprised of three practicing physicians, three practicing pharmacists, and one non-practicing physician, the Board is responsible for evaluating practitioner prescribing or dispensing behavior and determining appropriate educational or corrective interventions. Information regarding each case is reviewed by the DUR staff and presented with recommended actions to the Board for approval or modification The DUR staff is responsible for implementation of all Board actions.

The Board's primary emphasis is educational, providing information concerning drug therapy to practitioners via profile review, educational leaflets and direct provider contact. The Board does not censure nor withhold payment from Medicaid providers. However, in cases of obvious abuse, fraud, or malpractice, the Board is obligated to report such instances to the appropriate authorities.

Education Programs

OBRA 90 requires the Board to establish "...ongoing interventions for physicians and pharmacists, targeted toward therapy problems or individuals identified in the course of retrospective drug use reviews performed under this subsection." The Board, with recommendations from the DUR staff, approve all intervention strategies deemed necessary to improve the quality of care being rendered Idaho Medicaid clients. Remedial strategies include, but are not limited to:

1. Written personal communications from the Board to providers requesting information and documentation of specific drug use decisions. Suggested changes in prescribing or dispensing practices, are communicated via first class mail to help ensure the privacy of patient and provider related information;
   
2. Educational leaflets summarizing the mechanism, presentation and possible alternatives for a large number of common drug-related problems have been developed and distributed to providers
   
3. Cost graphics have been developed for several drug classes which summarize the relative cost implications and emphasize cost-effective alternatives.
   
4. Staff have developed and presented specific continuing education programs at various state and local professional meetings ; and
   
5. Direct, personal (face-to-face) contact with individual providers deemed repeat, or long-term irrational prescribers or dispensers may take place with members of the Board, qualified staff approved by the Board, or clinical consultant

Advantages of the ISU Program

The DUR program provides an interactive process of DUR development by Idaho health care practitioners explicitly for the benefit of Idaho Medicaid providers. The importance of this concept cannot be overemphasized and is perhaps the most critical factor in implementing a DUR program. A project staff has been assembled which is sensitive to the needs of Idaho providers and firmly committed to incorporating a "grass roots" approach to DUR. Success ultimately depends upon an ability to effectively identify and resolve clinically important drug problems, and an ability to gain the respect and support of Idaho health care practitioners.

Educational Resource

The DUR program has proved to be an extremely valuable resource to the students and faculty at Idaho State University as well to other sister agencies in the state. The Colleges of Pharmacy and Business have both used the Drug Utilization Review Project as an educational and teaching resource.

Professional and graduate students in the College of Pharmacy have actively participated in development of clinical criteria (practice standards), data collection and analysis. This experience aids students in understanding the difficulties of working with a complex databases as well as the strengths and weaknesses of DUR. This experience is an important component of a well rounded education and is possible only because the data is available on campus.

The College of Business also uses the DUR database to teach part of its medical-informatics program, providing students with a background in hospital, community and other medical information systems. Through the DUR project, both undergraduate and graduate students have been provided the ability to address real life problems by designing computer software and applications for use by health care practitioners and the community.

Assistance to Other State Agencies

Additionally, the DUR project has been able to assist the State Board of Pharmacy. The DUR staff were asked to help identify pharmacies which may not be adequately reviewing patient medication history prior to dispensing a prescription. This information was provided to the Board of Pharmacy for educational purposes, (i.e., non- punitive nature) to demonstrate OBRA 90 patient counseling requirements and potential expectations.

Continuing Education Programs

The Staff of the DUR project have used information gained from the patient data to develop continuing education programs for pharmacists in the state. The ability to discuss real - and ongoing cases greatly enhances the educational impact of such programs.

Ad Hoc Reporting Capabilities

The DUR staff have provided numerous ad hoc reports for the Medicaid Surveillance and Utilization division (SURs). Referrals from SURs generally involve suspected cases of excessive prescribing and/or recipient abuse or overuse of medications. Patient profiles can be easily generated using the DUR database for evaluation by the Board. Additionally, at the request of the Director of Health and Welfare, an extensive ad hoc report was generated analyzing the use of generic versus brand name drug products within the Medicaid program. No additional fees have been charged for these extemporaneous reports.

Patient Confidentiality

It should be noted that all patient identifying information and any other information which might lead to identification of health care providers has been removed or altered in order to maintain confidentiality of all patient data. The staff of the DUR project constantly maintain strict confidentiality.

All quotes in this proposal taken from the Conference Report to Accompany H.R. 5835, the Omnibus Budget Reconciliation Act of 1990, U.S. Government Printing Office, October 27, 1990.