Cha # 03 Drug Utilization Review

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CHAPTER # 03 DRUG UTILIZATION REVIEW
Definitions
1. It is an authorized, structured and on-going review of physician prescribing, pharmacist
dispensing and patient use of medication.
2. It is quality assurance tool in which drug use is evaluated against agreed criteria or
standard and if necessary advices on the change of practice to improve safety, efficacy
and cost effectiveness.
3. It is the process used to assess the appropriate use of drug therapy by engaging in
evaluation of the data on drug use in environment of health care setting against
predetermined criteria or standard.
Types of DUR
There are three types of DUR
i- Prospective DUR
ii- Concurrent DUR
iii- Retrospective DUR
i. Prospective DUR:
It is the evaluation of patient medication therapy before medication is dispensed to the patient.
This allows the pharmacist to identify and solve problems before medication is dispensed to the
patient because pharmacist routinely performs prospective review of medication is assessing
patient medication dosage and direction while reviewing patient medication data.
Prospective DUR can effectively play role in identification of drug- drug interactions e.g. if
patient is using warfarin to prevent blood clot and he is prescribed by another specialist with the
drug used for arthritis. The pharmacist while reviewing the prescription would note drug-drug
interactions that could cause bleeding in the patient, so he would inform the prescriber about the
interactions before this medication is dispensed.
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ii. Concurrent DUR:
It is the evaluation of drug therapy during the course of treatment e.g. Concurrent DUR can be
performed in an institutional setting where a patient often receives a multiple medication. The
pharmacist must note drug-drug interactions or duplicate therapy and inform the physician about
the change of medication such as antibiotics about dose adjustment on the basis of lab test.
iii. Retrospective DUR:
Retrospective DUR is the evaluation of drug therapy after the drugs have been used. The
pharmacist in retrospective DUR would identify the group of patient who are not taking the
medication according to the guidelines. E.g. a group of patients with asthma who are using oral
inhaled steroids, the pharmacist would inform the physician and encourage him to prescribe the
indicated drugs.
Commonly issues addressed by DUR
i. Drug-disease contraindications
ii. Drug-dosage modifications i.e. excessive dosage and insufficient dosage
modification.
iii. Drug abuse and misuse ( over or under-utilization )
iv. Drug-drug interactions
v. Drug-patient interactions ( age , allergic , gender , pregnancy )
vi. Therapeutic interchange or generic substitute.
Criteria:
These are pre-determined parameters of drug prescribing and use, established by DUR
committee for comparison to actual practice. These are set by qualified member of health care
team and supported by official compendia, unbiased drug info and peer review of literature.
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Threshold
It is the percentage set by the DUR committee that identifies the point at which drug use problem
exists. If threshold is met, it means there is no drug use problem. It may be 100 % or less than
100 %.
Interventions:
These are the activities selected by DUR committee to correct drug use problem, identified
during drug use monitoring and evaluation.
Aspects of Drug Use to Be Evaluated
It may be:
1. Justification for drug use
2. Process / Critical indicator
3. Outcome indicator
1. Justification for use
Justifications for use specify the condition under which the drug being used is evaluated i.e.
indication. For example,
Ceftazidime is specified for pseudomonas aeruginosa
Cimetidine is indicated for benign gastric and duodenal ulceration and GERD.
2. Critical indicators
Critical indicators specify various aspects of drug use being evaluated which should be
monitored during standard therapy. These include;
i. Documented appropriate indications
ii. Adverse effects
iii. Management of overdose
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iv. Dosing
v. Dosage form
vi. Administration
vii. Drug-drug and drug-food interactions
viii. Patient education etc.
3. Outcome indicators:
These are the anticipated results of therapy.
For example, reduction in fever and negative culture sensitivity test within 24 hours of
discontinuation of ceftazidine therapy
Similarly improvement in WBCs count may also be an outcome indicator.
Candidate drug
Drugs which are subjected to DUR program are termed as candidate drugs.
These drugs may belong to either of the following types.
i. High cost, high volume clinically important drugs.
ii. Used in high risk patients e. g in elderly patients, ICU patients or emergency
patients etc.
iii. Drugs having significant side effects e. g aminoglycosides.
iv. Drugs with narrow therapeutic index.
v. Drugs used for most common diagnosis.
vi. Drugs to be included in the formulary.
vii. Drugs recently added to the formulary.
viii. Drugs which may lead to misuse.
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DUR of Cimetidine
1. Justification for use
i. Short term management for active duodenal ulcer.
ii. Long term prophylaxis
iii. Benign gastric ulcer
iv. Gastric hypersensitivity conditions
v. Acid indigestion
vi. Soar stomach
vii. To prevent upper gastrointestinal bleeding in acute ill patients
2. Process/Critical indicators
i. Adverse effects
1-10 %
CNS: Dizziness, drowsiness, headache.
GIT: Nausea, vomiting, diarrhea.
Less than 1 %
Bradycardia, tachycardia and hypotension.
ii. Contraindications: Hypersensitivity to cimetidine
iii. Precautions/Warning:
Adjust the dose in renal or hepatic impairment.
iv. Toxicity
- Vomiting
- Diarrhea
- Hypotension
- Respiratory failure
- Restlessness
Toxic dose is 20 gm.
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Management:
- Gastric lavage
- Induction of vomiting
- Maintenance of supportive therapy.
v. Interactions
a. Drug-drug interactions: Benzodiazepines, -blockers, Ca-channel blockers and
lidocaine increase the serum concentration of cimetidine.
b. Drug-alcohol interaction: Avoid use with alcohol because alcohol causes
gastric irritations.
c. Drug-food interactions: Food decreases its absorption, therefore should be taken
at least 30 min before meal.
With coffee, it causes increased serum level of caffeine.
vi. Pharmacokinetics
1. Onset of action : 1 hour
2. Durations of action : 6 hours
3. Protein binding : 20%
4. Distribution: Can cross placenta as well as enter breast milk.
5. Metabolism : Partly hepatic
6. Bioavailability : 40-60 %
7. Elimination half-life :
8. Neonates : 3.6 hrs
9. Children : 1.4 hrs
10. Adults : 2 hrs ( Ele: t is 1.4 hr in children because in children the rate of metabolism is
high)
11. Peak concentration time: 2 hrs after I.M / I.V / oral administration.
12. Excretion: urine ( mostly unchanged )
vii. Dose :
a. Children: 20-40 mg/kg/day IM/IV/Oral
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b. Adult: 300 mg 6 hourly IM/IV/Oral
viii. Dosage form:
As Hcl salt.
Injection : 300 mg/ml
Suspension : 100 mg/5ml
Tablets: 200 mg, 400 mg.
ix. Drug-lab interactions
1. Raised ALT and AST
x. Monitoring test
Complete Blood Count (CBC)
Gastric PH
Liver function test
xi. Patient education :
Smoking decreases effectiveness of cimetidine.
Avoid use of ethanol
Inform prescriber of all prescriptions.
3. Discussion/conclusion:
Take 30 min before meal.
Let your physician know about kidney or liver disease.
If dose is skipped, then follow the routine schedule, never double the
dose.
Let your doctor know about pregnancy.
Should not be used in immune-compromised individual because raised
gastric PH may lead to an infection strong lodiasis.
Should not be used in child under 16 years of age.
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DUR of Vancomycin
A. Justification for use
For the treatments of patients with infection caused by:
Streptococcal species
Staphylococcal species
B. Process indicators
i. Adverse effects:
a. Oral
More than 10 %
GIT: Bitter taste, vomiting, nausea.
1-10 %
CNS: chills, fever.
Less than 1 %
Renal impairment, interstitial nephritis.
b. Parentral
More than 10 %
CVS: Hypotension, accompanied by flushing.
1-10 %
CNS: Chills, drug fever.
Dermatological: Rashes
ii. Contraindications: Hypersensitivity to vancomycin
iii. Warning: Use with caution in renal impairment, with ototoxic and/or nephrotoxic
drugs.
iv. Toxicity: Ototoxicity and nephrotoxicity.
Management:
Supportive care is advised to maintain GFR.
Haemo-filteration is recommended to be of benefit.
v. Drug interactions:
The effects of anesthetics, ototoxic and nephrotoxic agents are enhanced.
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vi. Pharmacokinetics
a. Absorption :
Oral: Poor
Parenteral: Erotic (not fixed)
Intra-peritoneal: 30 %
b. Distribution: Widely distributed in tissues and fluids except CSF.
c. Protein binding : 10-50 %
d. Elimination half-life: 5-11 hrs
e. Excretion: Mainly (80-90 %) through urine as unchanged, some through
faeces.
vii. Dose
(For normal renal functions)
1 gm. b.i.d
For prophylaxis dental, oral or respiratory tract surgery, dose is 1 gm 1 hr
before surgery.
viii. Dosage form
Capsules : 250mg/500mg
Infusion iso-osmotic with dextrose: 500mg/100ml, 1 gm/200ml.
Injection: 500mg, 1gm, 5 gm, 10 gm.
ix. Monitoring Test
a) Clearance > 60 ml/min: 1 gm or 10-15mg/kg b.d.
b) Clearance 40-60 ml/min: 1 gm or 10-15 mg/kg o.d.
c) Clearance less than 40 ml/min: dose is determined by serum
concentration.
x. Patient education
Inform prescriber of all prescriptions.
Red man syndrome, characterized by hypotension and rash, is not an
allergic response but is due to rapid infusion of vancomycin.
It should be given in 30 minutes.
It should be used with caution in breast feeding.
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Let your physician know about your pregnancy or intention to get
pregnant.
C. Discussion:
Because of its long half-life, it is scheduled to be dosed at 12 hours intervals and so peak
concentration and trough concentration determinations are advisable.
DUR of Prednisolone
A. Justification for use:
i. Chemical class: Glucocorticoids, systemic immune-suppressants.
ii. Asthma, Allograft rejection, SLE, Inflammation, anti-allergic.
B. Process indicators
i. Adverse effects:
Nausea , vomiting , diarrhea
Hyperglycemia
Nervousness , euphoria
Increase in appetite, obesity
Acne
Stretch marks
Ocular hypertension, myopathy.
Adrenal insufficiency
Osteoporosis
ii. Drug interactions:
a. Drug-Drug interactions:
Aspirin: The risk of ulceration is increased and the plasma level of aspirin is
Erythromycin: Erythromycin decreases the metabolism of prednisolone.
Anti-diabetics: The antidiabetic effect is antagonized by prednisolone.
Anti-diuretics: The antidiuretic effect is antagonized by prednisolone.
Theophylline: Increased risk of hypokaelemia when given concurrently with
prednisolone.
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b. Drug-Lab interactions:
Monitor calcium level.
Monitor WBC count.
Monitor renal function tests.
There is false increase in theophylline, cortisol and digoxin level in the
blood.
c. Drug-food interactions: No interaction has been reported yet.
iii. Dose:
Asthma: 40-50 mg daily for several days.
Inflammation: 10-20 mg initially for one week, then 60 mg daily for months to
years.
Chronic Obstructive Pulmonary disease: 30 mg for 7-14 days.
iv. Dosage form:
Tablets: 40 mg
Syp/Sus: 15 mg/5ml
Injection: 500mg, 1 gm.
v. Patient counseling
If taken for more than three weeks, then gradually decrease the dose
before stopping the medication (dose tapering).
Use for asthma, inflammation, cancer and psoriasis.
C. Outcome indicators
i. Systemic administration of prednisolone and bronchodilators relieves the
symptoms of asthma.
ii. Increased prognosis of Systemic Lupus Erythema-tosis (SLE).
iii. Decrease in inflammation
HOW TO ESTABLISH DUR PROGRAM IN HOSPITAL
The hospital DUR program is divided into four phases, each of which has different steps which
do require a bit explanation.
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These phases include:
Planning
Data collection and evaluation
Intervention
Program evaluation
A. PHASE-I : Planning:
It includes following steps:
1. Form the DUR committee:
DUR is primarily a medical staff function with pharmacists and nurse performance with
expertise. If a hospital formulary committee already exists, they may be given
responsibility for DUR or they may be given response of DUR subcommittee.
2. Policies and procedures:
Prior to monitoring and evaluation, the committee should draft the policies and
procedures that will govern its work. Following are the key elements, recommended for
inclusion in the DUR policies and procedures.
i. Designation as program;
The order of chief physician on establishing DUR should specify that DUR is a
program that is continuous. This is important to do so because medical staff should
understand that hospital is committed to ensure safe and effective drug use.
ii. Mission statement:
It includes major activities/goals of DUR program .The DUR committee in
collaboration with hospital pharmacy department will be responsible for appropriate ,
safe and effective drug use within the hospital.
iii. Committee makeup:
Normally DUR committee is composed of authoritative representatives responsible
for drug use in medicine, surgery, emergency and pediatrics. Pharmacy drugs info,
nursing and ad hoc representatives may be invited in the development of criteria, data
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evaluation, designing and intervention. The committee may have a chairman and
secretary and normally pharmacy representative or clinical pharmacologist is sacred.
iv. Frequency of meeting:
Initially monthly meeting may be necessary to discuss startup problems and make
corrections in program. Later quarter meeting may be sufficient.
v. Program cycle:
There are four phases of program cycle which are known as four phases of DUR.
vi. Aspects of drug use to be evaluated:
These include:
Justification for use
Process indicators
Outcome indicators
vii. Requirements for development of criteria;
A policy should be included that requires that drug use criteria be developed using a
variety of resources, including hospital experience, scientific literature and guidelines
for professional societies and that the list of references should be made available to
the medical staff.
viii. Dissemination of information:
The results of monitoring and evaluation are disseminated to appropriate hospital
personnel.
ix. Types of interventions:
A Policy should be developed that specifies major types of interventions be used to
correct drug use program.
x. Program evaluation:
Policy should specify that DUR program be evaluated at the end of cycle so that
improvement can be made to assess the clinical and economic impact to the hospital.
3. Identify all the areas of hospital where drugs are used:
The committee should identify all areas of lab where drugs are used e.g. emergency,
radiology, I.C.U, surgical and medical departments etc.
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Some departments such as medicines , pediatric and surgery will be involved in DUR
program in every cycle but other department such as radiology where drug use is not
extensive , may be included after three or four years .
4. Identify drugs for possible inclusion in the program:
It is impossible and unnecessary to monitor and evaluate every drug. Therefore, the
DUR committee must define priority drugs where improvement in use will result in
clinical and economic impact.
Two types of analysis are used:
i. ABC analysis:
It is a method by which drugs are divided according to their annual usage into;
Class-A items: 10-20 % of the items that accounts for 75-80 % of the
funds spent.
Class-B items: 10-20 % of the items and 15-20 % of the expenditure.
Class-C items: 60-80 % of the items and 5-10 % of the expenditure.
ABC analysis can be used to give priority to class-A items in making drug selection and
procurement for inclusion in DUR.
ii. VEN analysis:
In this system drug selection is made according to their clinical impact into;
Vital drugs: i.e. drugs that are potentially lifesaving (e.g. vaccines) or have
significant withdrawal effects such as regular supply is necessary (e.g.
propranolol, insulin, steroids).
Essential drugs: that are effective against less sever but significant form of
illness.
Non-essential drugs: drugs for minor or self-limiting illness, drugs that are of
questionable efficacy and drugs that have a high cost for marginal therapeutic
quality.
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5. Access resources available for criteria development, data collection &
evaluation and choose drug to be included in the program.
The committee may develop criteria itself, utilize hospital specialists and clinical staff or
use established criteria from unbiased drug reference literature.
It is reasonable to include twelve drugs initially and completing monitoring and
evaluation of one drug each month. Obviously, as interventions and re-evaluations begin
the work load of committee increases.
6. For each drug, select aspects of drug use to monitor and evaluate.
As it is impossible to monitor and evaluate all drugs used in the hospital, similarly, it is
impossible to address all aspects of use for each drug finally selected. Therefore the
committee must select the only most important aspect of use to monitor and evaluate e.g.
heparin is frequently used drug that has potential to cause serious consequences if not
used correctly. It is also used for critically ill patients. Internal bleeding or death may
occur if heparin is used when contraindicated, if side effects or over-dosage not
administered or if dosing which requires lab testing is not done properly. Patient with
heparin usually receives other drugs concurrently with significant potential for drug-drug
interactions. For these drugs committee decide to monitor contraindications, side effects,
dose and management of overdose, lab testing and clearance.
7. Select criteria and establishes performance threshold criteria or
statement about correct drug use.
Hospital DUR committee can use one of the following methods to develop criteria.
i. Use existing criteria set such as standard treatment guidelines developed by W.H.O or
American Society of Health System Pharmacists because these are unbiased criteria.
ii. Adopt existing criteria sets according to the need of hospital.
iii. Select its own criteria based on hospital developed treatment guidelines.
Once the criteria are set, then threshold is selected. Threshold is the percentage
established by committee that identifies the point at which non-compliance with drug use
evaluation criteria demands interventions.
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It may be set up to 100% 0r less than 100%. 100% threshold is used for potent drugs and
less than 100% is used for less potent drugs.
8. Establish methodology for data collection and evaluation and create a
schedule. This includes data elements, data sources, forms, personnel responsible and
sample size.
i. Data elements: It includes :
Prescriber name and specialty.
Drug name, dose, amount prescribed, duration and cost of drug.
ii. Data sources: It includes;
Patient history.
Lab record.
Pharmacy record.
iii. Forms: Special forms are designed to report the data in an orderly fashion.
iv. Personnel responsible: It means working individuals.
v. Sample size: It depends upon how much data to collect.
9. Educate the hospital staff about the DUR program and current criteria.
It is important to educate the medical and hospital staff about the objectives of DUR
program and build support for the program. Informal meetings with the hospital leaders
may be used to build support. Physician-pharmacist education may best be accomplished
by disseminating all or part of the DUR program policies and procedures, the evaluation
schedule and criteria for a drug. This dissemination (Spread Widely) may be done by
different methods such as memo or newsletters but using staff meeting would allow
dissemination of subject matters and interactions among staff members.
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B. PHASE-II: Data collection and evaluation
10.Collect data
The method of data collection varies greatly with the approaches. Approaches mean
perspective, concurrent and retrospective. In all cases forms will be necessary for
documenting results.
11.Evaluate data and determine if drug use problem exists.
Data evaluation is one of the most critical steps in a DUR program because the result of
such evaluation may bring changes in hospital policies, formulary additions or deletions,
prescribing restrictions and counseling of hospital staff. If threshold is not met, it
indicates a drug use problem, so cases of non-compliance should be reviewed to
determine if drug use was actually appropriate. If the committee determines that there is
drug use problem, then data should be evaluated to determine if the problem is
widespread or limited to a flow individual.
C. PHASE-III: Interventions
12.Disseminate results to the hospital staff.
Results can be disseminated (spread widely) using any of the following mechanism.
i. Weekly prescribing conference.
ii. Written DUR committee meeting minutes.
iii. Newsletters
iv. Ad hoc (formed, arranged or done for a particular reason only) meeting
v. Posting results on each ward.
13. If a drug use problem is found, design and implement interventions.
Interventions (Action taken to improve a medical disorder) can be educational and
operational and can target the groups or individuals whose performance was not in
compliance with drug use criteria.
Educational interventions: These include;
i. In-services educational program.
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ii. Formal and informal counseling.
iii. Letter to physician.
iv. Newsletters.
Operational interventions: These include;
i. Development of drug order forms.
ii. Changes in the hospital policies and procedures.
iii. Formulary additions and deletions.
iv. Prescribing restrictions.
v. Revising standard treatment guidelines and staffing changes.
14.Collect new data on problem drug to determine if drug use has
improved as a result of interventions.
Physician prescribing is monitored to determine effectiveness of interventions. For this
purpose 6-12 months duration is required which involve collecting the same data as in the
original DUR evaluation.
15.Disseminates (spread widely) results of re-evaluation:
Disseminate results of re-evaluation of DUR to medical staff.
D. PHASE -IV: Program evaluation
16. Evaluate all DUR program activities at the end of evaluation year and plan program.