Drug and Therapeutics Committees - A Practical Guide
(2003; 155 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcronyms and abbreviations
View the documentPreface
Open this folder and view contents1. Introduction
Open this folder and view contents2.Structure and organization of a drug and therapeutics committee
Open this folder and view contents3. Managing the formulary process
Open this folder and view contents4.Assessing new medicines
Open this folder and view contents5.Ensuring medicine safety and quality
Close this folder6.Tools to investigate the use of medicines
View the document6.1 Stepwise approach to investigating the use of medicines
View the document6.2 Analysis of aggregate medicine use data
View the document6.3 WHO/INRUD drug use indicators for health facilities
View the document6.4 Qualitative methods to investigate causes of problems of medicine use
View the document6.5 Drug use evaluation (DUE) (drug utilization review)
View the documentAnnex 6.1 Defined daily doses (DDD) of some common medicines
View the documentAnnex 6.2 DUE criteria on data collection form for amikacin
Open this folder and view contents7.Promoting the rational use of medicines
Open this folder and view contents8.Antimicrobials and injections
Open this folder and view contents9. Getting started
View the documentGlossary1
View the documentReferences
View the documentFurther reading
View the documentUseful addresses and websites
View the documentBack cover
 

6.5 Drug use evaluation (DUE) (drug utilization review)

Drug use studies using aggregate data or health facility indicators may indicate that there is over- or under-consumption of medicines, and qualitative studies may indicate why certain health staff and patients behave the way they do. However, such studies do not provide detail about the exact nature of the irrational use. Such details may concern incorrect medicine choices, incorrect dose, prescribing drugs that cause ADRs or drug interactions, and the use of expensive drugs when cheaper ones would do.

Drug use evaluation (DUE) is a system of ongoing, systematic, criteria-based evaluation of drug use that will help ensure that medicines are used appropriately (at the individual patient level). If therapy is deemed to be inappropriate, interventions with providers or patients will be necessary to optimize drug therapy. A DUE is drug- or disease-specific and can be structured so that it will assess the actual process of prescribing, dispensing or administering a drug (indications, dose, drug interactions, etc.). DUE is the same as drug utilization review (DUR) and terms are used synonymously.

Medication use evaluation (MUE) is similar to DUE but emphasizes improving patient outcomes and individual quality of life; it is, therefore, highly dependent on a multidisciplinary approach involving all professionals dealing with drug therapy. An MUE will assess clinical outcomes (cured infections, decreased lipid levels, etc.).

The goal of a DUE or MUE is to promote optimal medication therapy and ensure that drug therapy meets current standards of care. Additional objectives may include:

• creating guidelines (criteria) for appropriate drug utilization

• evaluating the effectiveness of medication therapy

• enhancing responsibility/accountability in the medicine use process

• controlling medicine cost

• preventing medication related problems, for example adverse drug reactions, treatment failures, over-use, under-use, incorrect doses and non-formulary medicine use

• identifying areas in which further information and education may be needed by health-care providers.


Once the main problem areas have been identified, (from aggregate data, health facility indicators, qualitative studies, other DUE studies, or even recommendations from DTC members), a DUE system can be established relatively quickly.

6.5.1 The steps of a DUE

The steps of a DUE are as follows. An example is shown in box 6.7.

STEP 1 Establish responsibility

It is the responsibility of the DTC to establish procedures for the implementation of a DUE programme; this includes appointing a responsible member of the DTC or a subcommittee to monitor and supervise the DUE process in the hospital or clinics. Ideally the DTC should establish annual plans, outlining which medicines or clinical conditions will be a part of the DUE process.

STEP 2 Develop the scope of activities and define the objectives

The DTC should decide upon the objectives of the DUE and the scope of the activities necessary. The scope can be very extensive or it can focus on a single aspect of drug therapy and will depend upon the type of problem identified, for example:

• overuse of a more expensive medicine when a cheaper equivalent is available, as revealed in aggregate data

• incorrect use (indication, dosage, administration) of a particular drug, as revealed in patient charts, medication error reports, ADR reports

• inappropriate choices of antibiotic, as revealed in antibiotic sensitivity reports

• a poor dispensing process, as revealed by patient complaints or feedback.


Due to the large number of medicines available at a hospital or clinic, the DTC must concentrate on those medicines with the highest potential for problems in order to get the most return on the work involved. These high-priority areas include:

• high-volume drugs

• expensive drugs

• drugs with a narrow therapeutic index

• drugs with a high incidence of ADRs

• critically important therapeutic categories, for example cardiovascular, emergency, toxicology, intravenous drugs, chemotherapy and narcotic analgesics

• antimicrobial drugs, prophylactic and therapeutic

• drugs undergoing evaluation for addition to the formulary

• drugs used for non-labelled indications

• drugs used in high-risk patients

• common clinical conditions often poorly treated.


STEP 3 Establish criteria for review of the medicine

Establishing DUE criteria is extremely important, and is the responsibility of the DTC. DUE criteria are statements that define correct drug usage with regard to various components, as shown in box 6.6. Criteria for the use of any medicine should be established using the hospital’s STGs (assuming that they have been correctly developed). In the absence of hospital STGs, criteria may be based on recommendations from national or other locally available satisfactory drug use protocols, other relevant literature sources, and/or recognized international and local experts. Credibility, and staff acceptance, of the DUE relies on using criteria that have been developed from reading established evidence-based medicine information from reputable sources and that have been discussed with prescribers.

BOX 6.6 COMPONENTS OF DRUG USE FOR DUE CRITERIA

uses: appropriate indication for drug, absence of contraindications
selection: appropriate drug for clinical condition
dosing: indication-specific dosing, intervals and duration of treatment
interactions: absence of interactions - drug-drug, drug-food, drug-laboratory
preparation: steps involved with preparing a drug for administration
administration: steps involved in administration, quantity dispensed
patient education: drug and disease-specific instructions given to patients
monitoring: clinical and laboratory
outcome, for example: decreased blood pressure, blood glucose, asthma attacks

Reviewing many criteria will make the DUE process more difficult, and may impair successful completion of the review. Therefore the number of criteria established for each medicine is often between 3 and 5. Once the criteria are established, thresholds or benchmarks are decided for each criterion in order to define the expectations or goals for compliance with the criteria. Ideally one would like 100% of all cases to comply with the criteria, but in reality this may not be possible, and a DTC might decide to set a threshold of 90-95% compliance below which they would instigate corrective action.

STEP 4 Data collection

Data may be collected retrospectively, from patient charts and other records, or prospectively, at the time a medicine is prepared or dispensed. Retrospective data collection may be quicker and is best accomplished away from the patient care areas and distractions. The advantage of a prospective review is that the reviewer can intervene at the time the medicine is dispensed to prevent errors in dosage, indications, interactions or other mistakes. A particular example of this is the computerized systems used in some pharmacies; here the computer warns the pharmacist if patient data being entered into the computer fails to meet established criteria and requires them to correct the problem(s) noted. Such a system can also provide a large database for use retrospectively.

Data must be collected from a suitable random sample of charts or prescription records from the health-care facility, usually selected by pharmacy personnel, but also by nurses or medical records personnel. The treatment of at least 30 patients, or 100 patients for common clinical conditions, should be reviewed per health facility or hospital. The larger the facility and the more practitioners, the larger the number of records needed for review and analysis. Data collection forms based on the criteria can be configured into simple ‘yes/no’ questions or may involve the filling in of open questions (see annex 6.2). Sources of data include patient charts, dispensing records, medication administration records, laboratory reports, ADR reports, medication error reports, antimicrobial sensitivity reports, and documented staff and patient complaints.

STEP 5 Data analysis

Data are tabulated in a form that corresponds to the criteria chosen for the DUE. The percentages of cases that meet the threshold for each criteria should be calculated and summarized for presentation to the DTC. A report of all DUE programmes that are being conducted should be prepared on a quarterly basis.

STEP 6 Feedback to the prescribers and making a plan of action

After information is presented (for example on inappropriate drug use or unacceptable patient outcome), the DTC should develop conclusions about the differences between actual and desired results. In other words, how do the actual results vary from the desired benchmark or threshold levels? The DTC should then decide what follow-up action is necessary and whether to continue, discontinue or expand the functions of the DUE in question. Recommendations should include specific steps to correct any drug use problem that is evident from performing the DUE. For example, if a specific medicine is being prescribed at too high a dose, the recommendations need to specify in detail how the dosing of this medicine can be improved. Interventions to improve drug use would include feedback to the prescribers and may also include:

• education, for example letters, in-service education, workshops, newsletters, face-to-face discussions

• institution of drug order forms

• institution of prescribing restrictions

• changing the formulary list and/or manual

• changing the standard treatment guidelines

• using another DUE or continuing the present one.


STEP 7 Follow-up

In every DUE, follow-up is critical to ensure appropriate resolution of any problems. Did an intervention achieve its objective? If an intervention is not evaluated, or drug use problems are not resolved, then the DUE will have been of no use. As a part of a follow-up plan the DTC must assess the need to continue, modify or discontinue the DUE. Thus, DUE activities should be evaluated regularly (at least annually) and those that do not have a significant impact on drug use should be redesigned in order to provide measurable improvements. Common problems associated with DUEs include unclear responsibilities for different activities, poor prioritization of problems, lack of documentation, lack of personnel and inadequate follow-up. If follow-up is adequate, prescribers are likely to improve their performance in all areas knowing that they may be reviewed in the future!

BOX 6.7 DRUG USE EVALUATION AT A US HOSPITAL

In 1993 the quality assurance coordinator reported to the DTC that the rate of postoperative infections for abdominal surgery was considerably higher than the national average. The pharmacy director reported that ceftriaxone, a costly and inappropriate drug, was used for these patients. He advised that current formulary drugs, either cefoxitin or cefotetan, would be more appropriate. The DTC decided to undertake a DUE for prophylaxis of abdominal surgery wound infection. The chief surgeon was a member of the DTC and he agreed with their decision to conduct a DUE using criteria developed from recently published recommendations in the Medical Letter.

• Data collection period: January-December 1994
• Total number of cases: 162
• Date of report: January 1995
• Number of cases reviewed: 120 (74%)

Criteria

Benchmark (%)

Compliance per quarter (%)

   

1st

2nd

3rd

4th

1 Correct antibiotic selection

100

70

85

94

100

2 Correct dose

95

65

90

94

97

3 Dose: 0-2 hours preoperative

95

30

52

89

94

4 Postoperative dose: for dirty surgery only

98

78

89

82

91

5 No postoperative infection

96

90

93

96

100

6 No ADRs to drugs

97

97

100

87

97


Conclusions after the first quarter

• Criterion 1: non-first choice antibiotics (e.g.ceftriaxone) for the indicated procedure were being used instead of recommended ones (e.g. cefoxitin or cefotetan)

• Criterion 2: unnecessarily high doses of antibiotics were being prescribed

• Criterion 3: preoperative doses were being delayed because the current pharmacy procedure was to send antibiotics to the operating room rather than the preoperative area

• Criterion 4: patients not meeting the criteria for dirty surgery were also receiving antibiotics

• Criterion 5: relatively high postoperative infection rate may be reduced with increased compliance with criteria


Recommendations

• Send letter to all surgeons with information about (1) current postoperative infection rates versus the national average, (2) criteria and recommendations from the Medical Letter, (3) results of the DUE data collection, (4) estimated cost impact of inappropriate drug selection and unnecessary drug use

• Remove cefoxitin from the formulary because of its disadvantages (cost and short half-life) compared with cefotetan

• Change procedures to administer preoperative doses in the preoperative area rather than the operating room, and instruct nursing and pharmacy staff accordingly

• Add approved antibiotics to the floor stock in the preoperative area for emergencies


Actions

• Chief surgeon informed the surgical committee about the DUE and the criteria in 1994

• A letter was sent to all surgeons in April 1994 detailing the rationale for using cefotetan, not ceftriaxone, for prophylaxis of abdominal wound surgery

• Cefoxitin was removed from the formulary: ceftriaxone could not be removed due to its use for other indications

• New procedures for administration were adopted in June and staff training started in July 1994

• Antibiotics were added to preoperative floor stock in July 1994


Follow-up

• Criterion 1: Benchmark met in 4th quarter - education of surgeons led to an improvement in selection

• Criterion 2: Benchmark met in 4th quarter - education of surgeons led to an improvement in dosing

• Criterion 3: Benchmark was not met in 4th quarter despite all the activities and was considered unrealistically high because of many factors in emergency procedures; it was therefore reduced to 93%

• Criterion 4: Education decreased unnecessary postoperative antibiotics for a short time; then surgeons began to return to old practices. The DTC sent individual letters to specific surgeons and the practice improved but still did not reach the benchmark. Cases of non-compliance were to be reported to the DTC for peer review and recommendations

• Criterion 5: Benchmark met in third quarter

• Criterion 6: Allergic reactions increased in the third quarter because of the change in floor stock procedures and the preoperative nurse failing to screen for patient allergies (previously the pharmacy screened for allergies before dispensing). Nurses then received in-service training and allergic reactions decreased, meeting the benchmark in the 4th quarter.


Source: C. Olsen, MSH

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