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Evaluasi Penggunaan
Obat
Endang Yuniarti, S.Si.,M.Kes,Apt
Objectives

 Understand the concept of DUE


 Understand the process for implementing
and performing a DUE
 Discuss the use of a DUE for improving
pharmaceutical therapy
 Prepare criteria and thresholds for a DUE
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Rational Medicine use

WHO:
The rational use of drugs requires that
patients receive medications
appropriate to their clinical needs, in
doses that meet their own individual
requirements, for an adequate period
of time, and at the lowest cost to them
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and their community

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Rational medicines use:

 Appropriate indication - prescribing is based


on sound medical considerations
 Appropriate medicine, considering efficacy,
safety, suitability for the patient, and cost
 Appropriate dosage, administration, and
duration of treatment
 Appropriate patient – no contraindications
exist, and the likelihood of ADR is minimal
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 Correct dispensing, including information for


px about the prescribed medicines
 Patient adherence to treatment.
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The Drug and Therapeutic Committee (DTC)

DTC is responsible for developing policies


and procedures to promote rational medicine
use, include:
 Management of the approved medicine list
or hospital formulary
 Ongoing drug use review (drug use
evaluation)
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 Adverse drug event reporting and


implementation of safe medication
practices
Defined

 An ongoing, systematic, criteria-based


program of medicine evaluations that
will help ensure appropriate medicine
use. If therapy is determined to be
inappropriate, interventions with
providers or patients will be necessary
to optimize pharmaceutical therapy.
 This terminology is similar to that
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drug use review (DUR) and medication


use review (MUR).

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Defined

 Medication-Use Evaluation:
A performance-improvement method
that focuses on evaluating and
improving medication-use processes
with the goal of optimal patient
outcomes.
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Objectives of DUE

 Ensuring that the pharmaceutical therapy meets


current standards of care
 Promoting optimal medication therapy
 Preventing medication-related problems
 Identifying specific medicine use problems that
require further evaluation
 Creating guidelines (criteria) for appropriate
medicine use
 Defining thresholds for quality of medicine use
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 Enhancing accountability in the medicine use


process
 Controlling pharmaceutical cost

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Find the problems

Many of these problems can be identified from:


1. other DUE studies,
2. a review of aggregate data in the hospital (e.g.,
most costly medicines, most prescribed
medicines, ADRrecords), medical chart reviews,
hospital and clinic medicine use indicators, or
3. Recommendations of DTC members. Regular
meetings of the DTC and assessments of quality
measurements in the health care system should
be able to identify problems that can be
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addressed in a DUE for resolution.

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Set the program

 The program should measure and compare


the outcomes of patients who received drug
therapy in concert with approved criteria
versus those that did not.
 Selection of agents (drugs): high-use, high-
risk or high-cost.
 Drug use criteria: diagnosis related,
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prescribed related, or drug-specific.

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Selection of drugs

 High cost, high volume, clinically important


drugs (identified and selected by performing
ABC/VEN analyses or reviewing procurement
documents);
 Used in high-risk patients (elderly, intensive
care, pediatric, etc.);
 Significant side effects, narrow therapeutic
index;
 Used in most common diagnoses;
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 Under consideration for formulary addition;


and
 Recently added to formulary.

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Drug Use Criteria

Diagnosis related:

Diagnosis-related criteria identify indications


for which select drug(s) may be appropriate
for a given disease state.
For example, the use of selected antibiotics
for Community Acquired Pneumonia. Use of
other AB would fall outside the approved list
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and require follow up.

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Drug Use Criteria

Prescribe related

This criteria identify specific physicians whom


the P&T committee has determined may use
certain drugs.
For example, selected antibiotics may be
limited to infectious disease specialists or
drotrecogin alfa may be limited to critical care
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specialists.

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Drug Use Criteria

Drug-specific

This criteria focus on specific aspects of a


select drug such as the dose or dosing
frequency.
For example, the dosage regimen of a low
molecular weight heparin might be reviewed.
Dosage regimens outside the criteria would
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require action.

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Select criteria

 Pharmacists, working with key physicians, develop


criteria for drug use evaluation.
 The criteria should be focused and limited.
 Select three to five criteria to evaluate that are
meaningful and simple to collect.
 If possible, concurrent (prospectively) rather than
retrospectively (chart review)
 The criteria should include a number of patients to
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be reviewed and the time period.


 The criteria are presented to the P&T committee
for their review and endorsement prior to
commencing data collection.
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Collect and process data

 Technology may be used to collect or


screen data: Hospital Information
System, Pharmacy Information System
 The use of trend graphs or control charts
are helpful in identifying opportunities for
improvement
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The results of DUE

 The result of a DUE may be validation


that drug use is appropriate and safe.
 However, it may also indicate an
opportunity for improving the way a drug
is used.
 It may be beneficial to form a task force
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to develop an action plan.

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The Action Plan

 The task force : key physicians, nurses,


pharmacists and other health care
professional
 The action plan may include development of
drug use guidelines, preprinted orders,
medication order entry rules, professional staff
education, formulary changes, or a
combination of these actions.
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 The DUE results and action plan are


presented to the P&T committee for
consideration.
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Diskusi

prosiding-semnasffua2013-2-evaluasi-
penggunaan-antibiotika.pdf
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A Stepwise Approach to DUEs

Step 1. Establish Responsibility


Step 2. Develop Scope of Activities
Steps 3 and 4. Establish Criteria,
Define and Establish Thresholds
Step 5. Collect Data and Organize Results.
Step 6. Analyze Data
Step 7. Develop Recommendations and
Action Plan
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Step 8. Conduct DUE Follow-up

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Step 1. Establish Responsibility

 Responsibility falls to the DTC or a subcommittee


of the DTC that functions only to monitor DUEs
in the hospital or clinic. The DTC or a
subcommittee must establish procedures that
will govern the committee in its activities
concerning medicine use review and evaluation.
As part of the responsibility of the DUE function,
the DTC must establish a plan, outlining which
medicines will be a part of the DUE process. This
plan needs to be updated and evaluated each
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year.

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Step 2. Develop Scope of Activities
 High-volume medicine use
 Medicines with a low therapeutic index
 Medicines with a high incidence of ADRs
 Expensive medicines
 Medicines that are critically important, including those in
the following categories: cardiovascular, emergency,
toxicology, oncology, intravenous medicines, and narcotic
analgesics
 Antimicrobial medicines, both prophylactic and therapeutic
 Injections
 Medicines undergoing evaluation for addition to the
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formulary
 Medicines used for off-label indications
 Medicines used for high-risk patients

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Steps 3 and 4. Establish Criteria, Define and
Establish Thresholds

Process indicators
 Indications— specific uses for the medicine in
question
 Dose— specific doses for any approved indication
for appropriate duration
 Quantity dispensed—correct number of doses
administered
 Preparation—steps involved with preparing a
medication for administration
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 Monitoring—laboratory test necessary and intervals


of testing during the use of the medicine

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Steps 3 and 4. Establish Criteria, Define and
Establish Thresholds

Process indicators (continue)


 Contraindications—known contraindications
 Drug interactions—significant medicine
interactions, including medicine-medicine,
medicine-food, and medicine-laboratory
 Administration—specific steps necessary to
administer a medicine, especially for injectables
 Patient education—instructions and education
that a patient should receive with the medicine
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Steps 3 and 4. Establish Criteria, Define and
Establish Thresholds

Outcome indicators—specific outcomes to be


realized from medicine use
 Lowered blood pressure, stabilized blood
glucose, and fewer migraine and asthma attacks
 Decreased visits to the emergency room,
decreased hospitalizations
 Improved patient quality of life (obtained from
questionnaires)
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Steps 3 and 4. Establish Criteria, Define and
Establish Thresholds

Pharmacy administration indicators


 Correct cost to patient
 Accurate billing records
 Accurate dispensing records
 Appropriate use of generic medicines or therapeutic
equivalents
 Appropriate use of formulary medicines
 Appropriate quantity dispensed
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Steps 3 and 4. Establish Criteria, Define and
Establish Thresholds

After developing criteria, the DTC must establish a


threshold or standard (benchmark) against which
the criteria will be judged. A threshold refers to the
percentage of charts or records that will meet or
exceed the established criteria for the medicine.
Ideally, this threshold will be 100 percent, but
realistically, a smaller percentage will be more
appropriate to account for exceptions to routine
medicine prescribing. Therefore, a threshold of 90
to 95 percent is typically used for many criteria,
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but each instance must be carefully analyzed


before reaching a conclusion.

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Contoh:

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Step 5. Collect Data and Organize Results.

Prospective studies (obtained from prescription


records)
 Indication
 Dose
 Duration of therapy
 Dosage form and route of administration
 Potential medicine interactions
 Appropriate therapy and medicine selection
(corresponds to STGs)
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 Therapeutic duplication
 Contraindications
 Quantity dispensed

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Step 5. Collect Data and Organize Results.

Retrospective studies (obtained from


prescription, medical records, laboratory
records)
 Laboratory monitoring
 Monitoring therapeutic use of high-cost
medicines
 ADRs to medications
 Correct use of generic or therapeutic
equivalents
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 Patient outcomes from pharmaceutical


therapy

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Step 5. Collect Data and Organize Results.

 Collection of the data is performed by


reviewing a suitable sample of charts or
prescription records from the health care
facility, usually by selected pharmacy
personnel. At a minimum, 50 to 75 records
should be reviewed at each health care
facility.
 The larger the facility and the more
practitioners who are available, the larger
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the percentage of records that would need to


be reviewed and analyzed.

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Step 6. Analyze Data

Data are collected, tabulated, and analyzed to see


if criteria and thresholds are met. The following
important steps should be completed when
analyzing data—
 Tabulate results for each indicator
 Analyze results to see if the criteria are met and
the thresholds are not exceeded
 Determine why thresholds are not met
 Analyze data quarterly or more frequently
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 If a threshold is not met, it may indicate a


medicine use problem that requires the attention
of the DTC.

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Step 7. Develop Recommendations and
Action Plan

Recommendations should be prepared for


the DTC to address the following—
Inappropriate medicine use
Unacceptable patient outcomes
Methods to resolve any medicine use
problem
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Intervention strategies
1. Educational strategies: training of prescribers,
printed materials, approaches based on face-
to-face contact
2. Managerial strategies: monitoring,
supervising, and feedback, selection,
procurement, and distribution, prescribing
and dispensing approaches
3. Economic strategies: price setting, capitation-
based budgeting, reimbursement and user
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fees, insurance.
4. Regulatory strategies: medicines registration,
limited medicines list, prescribing restrictions,
dispensing restrictions
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Types of interventions

1. In-service/continuing education
programs
2. Written guidelines for drug use
3. Development of special drug order forms
4. Changes in hospital policies and
procedures
5. Formulary additions and deletions
6. Prescribing restrictions
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7. Formal and informal counseling

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Step 8. Conduct DUE Follow-up

 Follow-up in every DUE is critical to ensure


resolution of any unresolved medicine use
problems. The DUE may have identified new
problems that need to be resolved within the
health care system.
 If the problems are not resolved, then the DUE
will have little usefulness to the health care
system. As a part of a follow-up plan, the DTC
must assess the need to continue, modify, or
stop the DUE activity depending on the results of
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each specific medicine review.

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Contoh DUE

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