What does DUR mean to you? Definitions and purposes abound

Ultimately, it should provide a path

The phrase drug utilization review, or DUR, takes several different shapes and meanings, depending on the situation and whom you’re talking to. Its purpose varies too, often swaying with current issues and problems in pharmacy.

DUR first appeared with the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90). Its goals: Reduce Medicaid fraud and ensure that patients receive appropriate medications. DUR has been used in various practice settings to cut costs in hospital pharmacies. Some pharmacies turn to DUR to help reduce medication errors.

The Pharmaceutical Care Management Association (PCMA) says DUR is a "structured, ongoing program that interprets patterns of drug use in relation to predetermined criteria and attempts to prevent or minimize inappropriate prescribing. DUR may be conducted retrospectively or prospectively, and OBRA ’90 mandated both types."1

OBRA ’90 did indeed mandate both prospective and retrospective DUR. As a result of OBRA ’90, every state is to offer patient drug counseling to all Medicaid patients and provide a DUR program for covered outpatient prescriptions "in order to assure that prescriptions (i) are appropriate, (ii) are medically necessary, and (iii) are not likely to cause 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 as well as potential and actual severe adverse reactions to drugs including education on therapeutic appropriateness, over-utilization and under-utilization, appropriate use of generic products, therapeutic duplication, drug disease, contraindications, drug interactions, incorrect drug dosage or duration of drug treatment, drug allergy interactions, and clinical abuse/misuse."2 Additionally, DUR must "provide for a review of drug therapy before each prescription is filled or delivered to an individual."2

The terminology can be confusing. Some refer to DUR but use DUE, or drug use evaluation, to mean the same thing. Others say DUE evolved from, not into, DUR. Patrick Malone and colleagues in their book Drug Information, a Guide for Pharmacists,3 hold to this latter evolution of terms and add that the prime difference between DUE and DUR is that DUR is more retrospective. They add that OBRA ’90 refers to this function as DUR, which can be more confusing. Here is their generally accepted differentiation of the terms: "In some cases, authors have distinguished the two by stating that DUR uses pharmacy claims data, whereas DUE includes use of patient chart data."3

MUE

"There are two very distinctive types of retrospective drug evaluation," Barry Browne, PharmD, coordinator of drug information at Scott and White Hospital and Health Plan in Temple, TX, tells Drug Utilization Review. "There is the MUE, or medication use evaluation, which many used to call DUE. An MUE is truly a medication use evaluation. It can be conducted prospectively, although that’s difficult to do, concurrently, or retrospectively. Most of our MUEs are done concurrently. That is, the patient is still in the hospital, but the evaluation is performed typically one day after the drug order is written and filled. For example, we might double-check today for appropriate use and dosing of gentamicin in a patient with elevated serum creatinine for an order that was written yesterday. Unfortunately, this type of check can’t always be done prospectively, or before the order is filled and dispensed."

MUEs meet the requirements of the Joint Commission on Accreditation of Healthcare Organizations, says Browne. At Scott and White, MUEs also go through the pharmacy and therapeutics (P&T) committee. "We choose the drug or drug class to evaluate based on three criteria. The target drug or drug class will be one that either has high volume, high risk, or is problem-prone.

"Although the MUE subcommittee is composed of medical staff, most of the work associated with MUEs is performed by the pharmacy department. At any given time, our institution will have six to seven ongoing MUEs. We’ll do an initial review of the drug. If there’s no problem, that’s the end of it."

If a review finds a problem, the data are used to perform an intervention, Browne says. "An intervention can be in the form of education, a change in the way an order is to be written, or a change in policy. We’ll wait an appropriate amount of time for the change to be implemented, typically one to six months, then perform a second evaluation. If, at that time the problem has been solved, that’s the end of the process. If the problem still exists, we do another intervention. Most MUEs require just one round of evaluation and intervention. Others require as many as three."

Browne cites proton pump inhibitors as an example, saying that in a three-year period he and his staff performed three evaluations of the drug class, with subsequent interventions.

The education efforts are typically interdisciplinary, involving prescribers, nurses, and pharmacists, he notes. "It’s difficult to make an effective change if the entire team isn’t aware of and supportive of the change," he says. "Besides which, Joint Commission started requiring multidisciplinary work a number of years ago."

These educational venues can be in the form of nursing inservices, a description of the change published in the quarterly P&T newsletter, order clarification, or a change in preprinted orders, for a change in doses, for example.

Browne says there is no specific form his team uses for MUE or DUR. "It’s more a matter of using a data collection form, and that form and its components vary from one evaluation to the next."

DUR

"When I think of DUR," Browne says, "I think of a retrospective review of pharmacy trends in overuse of a particular drug or drug class. These trends often appear as a result of direct-to-consumer advertising campaigns or from heavy detailing from pharmaceutical reps. I think of dredging through pharmacy claims data. DUR involves more patient care and cost issues than does MUE. We can identify prescribing trends and work on cost containment with DUR."

Although DUR extends beyond Medicaid recipients, many health care professionals associate DUR with Medicaid. "It’s a valid association," says Browne. "Many people had not heard of DUR until they learned about the components of OBRA ’90."

The DUR Board for the State of Kansas describes the DUR for Medicaid recipients on its Web site at www.pharm.ukans.edu/dur/. Retrospective DUR occurs after the medication has been dispensed. "The computer software compares and analyzes varying drug use criteria with both pharmacy and medical claims to identify potential drug therapy problems."4 Problem areas analyzed include:4

• drug-allergy contraindications;

• drug-disease contraindications;

• drug-drug interactions;

• therapeutic duplication;

• incorrect dosage or duration of therapy;

• overutilization;

• underutilization;

• clinical abuse or misuse.

The computer alerts DUR staff to potential problems, which staff then evaluate. One problem that hospital and community pharmacists face with non-Medicaid patients is solved here. The Medicaid claims process allows for analysis of drugs prescribed by different providers and those filled at different pharmacies. By evaluating data for multiple patients from the same providers, trends in prescribing and dispensing habits can be identified. As with other forms of MUE and DUR, intervention occurs when problem areas are identified. The goal of this DUR is to improve "drug therapy, patient outcomes, and quality of care."4

Health Information Designs (HID), an organization that handles Medicaid DUR programs to satisfy the requirements of OBRA ’90 for several states, performs both patient-specific therapeutic DUR and provider profiling.5 HID describes the three main steps involved in patient-specific programs:5

1) computer-based analysis of patient-specific drug and medical claims histories using therapeutic criteria to identify high-risk drug therapy cases;

2) review of the 12- to 18-month drug medical history profiles by clinicians to confirm the clinical significance of the computer-identified problems;

3) issuance of education alert letters to physicians and pharmacists involved in treating patients at high risk for drug-induced illness.

Prospective DUR

Prospective DUR occurs before a prescription is dispensed. The U.S. Pharmacopeia (USP) and the American Pharmaceutical Association (APhA) have put their heads together to help enhance the effectiveness of prospective DUR. Their effort was born from discussions in 1996 detailing situations, mostly outpatient, in which pharmacists were presented with "test" prescriptions. Pharmacists were given two prescriptions for one patient, for two drugs that interact with one another. In some cases, pharmacists overrode the drug interaction alerts from their computers and still filled the prescriptions.

"We identified four areas where there were issues," says Thomas Fulda, USP program director for DUR. "First and foremost is the issue of the criteria used to drive DUR. There is a need to develop evidence-based criteria."

Fulda referred to an article in Current Therapeutic Research in which various drug information sources were examined, including the American Hospital Formulary Service Drug Information, United States Pharmacopeia Drug Information, Drug Facts and Comparisons, Goodman and Gilman’s Pharmacological Basis of Therapeutics, and Drug Reax from Micromedex. The references were compared to each other by looking at five therapeutic categories, then asking: For any drug-drug or drug-class interaction listed in one reference, what is the likelihood that that same interaction will appear in two of the references? In three? In four? Secondly, for interactions appearing in two or more references, what is the likelihood the references agree on the clinical significance of those interactions?

"The results showed that the likelihood of an interaction appearing in two or more of these references is increasingly infrequent with the greater number of references examined," Fulda says. "That is, it’s much more common to find an interaction listed in only one reference and not in two. It’s actually rare to find the same interaction listed in three or more of the references. Furthermore, when interactions did appear in two or more references, those references disagreed on the clinical significance of the interaction.

"Several other studies have been reported since then, including one in which results of data of DUR alerts collected from 41 pharmacies showed that pharmacists override 88% of alerts generated by their computers."

Fulda says the reasons pharmacists gave in this study for overriding the alerts included: 1) the pharmacist already knew about the potential danger but didn’t believe it to be significant, and 2) the pharmacist didn’t believe the alert to be of any clinical significance to a particular patient.

"These studies point out some of the problems associated with DUR," says Fulda. "Based on the drug information evaluation, the quality of data supporting the criteria for DUR alerts is definitely in question."

The second focus for Fulda and colleagues is the adequacy of prospective DUR.

"DUR system users should be able to query their computers to determine the number of alerts generated by their systems," Fulda says. "For example, they should be able to learn the number of alerts generated for potential interactions between digoxin and quinidine. But if you ask pharmacists in chains or hospitals to do this, or if you ask the PBMs, they can’t do it."

The systems aren’t collecting the information, Fulda says. "By the time the pharmacist sends the alert back, the claim has already been adjudicated. If the pharmacist intervenes, another prescription and claim transaction must take place."

A third issue is the quality of systems design. "There are discrepancies in the way different systems do things," says Fulda. Based on these differences and the various ways items are flagged, one system may give an alert, but another system may not.

A fourth issue deals with the professional practice environment.

"All the systems use criteria packages from First DataBank," Fulda says. "These packages take a very comprehensive approach and flag situations beyond just those with significant clinical consequences. This becomes a double-edged sword. Pharmacists get too many inconsequential alerts, so they override and ignore alerts. At the same time, pharmacists are afraid to have a system that is too tightly focused as that kind of system might overlook several types of potential problems and not alert the pharmacist to situations that they might otherwise overlook. That side of the sword poses potential liable suits."

Fulda and his colleagues have written a paper based on their evaluation of these four issues, which is pending publication at this time. In this paper, under the lead authorship of Elizabeth Crischilles, the team also presents recommendations based on its evaluation. (DUR will report the citation of the article as soon as it is known.)

"The Academy of Managed Care Pharmacy is in the very early stages of a project to solve these problems," Fulda says. "The first step is to identify drug-drug interaction criteria that are evidence-based and have significant clinical outcomes. One possible part of the solution is to prevent a pharmacy claim from being adjudicated in the computer unless the pharmacist has done something in response to any alerts that appeared when the prescription order was entered.

"Our main concern has been the science behind the criteria," Fulda adds. "It’s then up to those who use the DUR systems and who are involved in developing them to see that the criteria are correctly implemented and that pharmacists are presented the depth of focus that both protects the patient and helps ensure that pharmacists don’t overlook potential medication problems."

While important to patient care, prospective DUR can be difficult to perform in any practice setting, Browne says. "Pharmacists are only as empowered as the information available to them. Comprehensive prospective DUR can be limited to the hospital pharmacist who doesn’t yet have lab data. The community pharmacist can be limited by not having full patient medical history or by simply not being aware of other drugs that patients might be taking that they buy from other pharmacies across town."

Still, Browne adds, "Prospective DUR is, or should be, exercised in every pharmacy setting. Each time a drug is dispensed, whether in a community pharmacy, a hospital pharmacy, a home health pharmacy, or a mail-order pharmacy, pharmacists need to perform prospective DUR based on the patient information they have at hand," says Browne.

Goals of DUR

Browne tells DUR, "Cost is not part of the equation we use in determining which drugs to evaluate for DUR or MUE. In fact, Joint Commission said several years ago that it did not want cost entering into the equation at all." As stated by the Kansas Medicaid DUR Board, the goal of DUR for its Medicaid recipients is to improve "drug therapy, patient outcomes, and quality of care."4 One of the initial goals of DUR, according to OBRA wording, was to reduce Medicaid fraud. Therefore, the goals of DUR, just like the definitions, terminology, and types of DUR, are many and appear to change with trends in pharmacy.

Recently, PCMA immediate past president John Thornton, called on members of pharmacy to form a task force to reduce medication errors by developing enhanced DUR systems. During his farewell address in November, Thornton discussed the consequences of medication errors that occur in prescribing and dispensing and said that, "No one in American healthcare is in a better position to take a lead role in addressing this problem than the members of PCMA." He added that the pharmaceutical benefits management companies cannot tackle this task alone. "Designing and implementing the kind of improved drug utilization review systems that will be capable of significantly reducing medication errors will require the cooperation of every segment of American health care."

In addition to PCMA, Thornton anticipates participation in the task force from the American Pharmaceutical Association, the Academy of Managed Care Pharmacy, the National Association of Chain Drug Stores, the National Council on Prescription Drug Programs, and key leaders such as J. Lyle Bootman of the Arizona University School of Pharmacy.

Professional duty

The benefits of DUR are not restricted just to patients. Pharmacist and attorney, Nicholas J. Lynn, writes in a continuing education lesson: "One of the better known developments in the 1990s that signaled society’s recognition and acceptance of the pharmacist as a unique and vital member of the health care team was the enactment of the patient counseling and drug utilization review (DUR) requirements of the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)."6 Lynn maintains that performance of DUR by pharmacists, both retrospective and prospective, helps ensure their status as professionals. It also holds pharmacists liable, responsible to carry out their professional duty. However, by following guidelines set forth in OBRA ’90 for DUR and patient counseling, a pharmacist helps protect himself professionally. Lynn writes, "A pharmacist should view the OBRA ’90 requirements as more than rules that must be complied with; they are, in fact, a federally mandated risk management program."6

Components to Include in Patient Counseling6

the name and description of the medication

the route, dosage form, route of administration, and duration of drug therapy special directions and precautions for the preparation, administration, and use of the drug by the patient

common, severe or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the acts required if they occur

techniques for self-monitoring drug therapy

proper storage of drugs

prescription refill information

action to be taken in the event of a misdose


References

1. Just the Facts: Q&A. Pharmaceutical Care Management Association. www.pcmanet.org/fcts_ai.html

2. Conference Report to Accompany H.R. 5835, the Omnibus Budget Reconciliation Act of 1990, U.S. Government Printing Office, Oct. 27, 1990.

3. Malone PM, Mosdell KW, Kier KL, et al, eds. Drug Information: a Guide for Pharmacists. Stamford, CT: Appleton & Lange; 1996.

4. Kansas Medicaid DUR home page at www.pharm.ukans.edu/dur/.

5. Health Information Designs home page at www.hidinc.com/ext_db1a.php3.

6. Lynn, NJ. Avoiding Malpractice in Today’s Litigious Society. Continuing education monograph; June 1998 at www.ncpanet.org/CONTEDU/malpractice.html

Sources

Barry Browne, PharmD, Coordinator of Drug Information, Scott and White Hospital and Health Plan, 2401 S. 31st St., Temple, TX 76508. Telephone: (254) 724-5287.

Thomas Fulda, USP Program Director for DUR, U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852. Telephone: (301) 816-8596.